Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-30 @ 5:10 PM
Study NCT ID:
NCT00763867
Status:
COMPLETED
Last Update Posted:
2014-07-23
First Post:
2008-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluating the Effectiveness of Sildenafil at Improving Health Outcomes and Exercise Ability in People With Diastolic Heart Failure (The RELAX Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D054144', 'term': 'Heart Failure, Diastolic'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D000068677', 'term': 'Sildenafil Citrate'}], 'ancestors': [{'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jenny.ibarra@duke.edu', 'phone': '919.236.3291', 'title': 'Jenny Ibarra', 'organization': 'Duke University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks', 'otherNumAtRisk': 103, 'otherNumAffected': 72, 'seriousNumAtRisk': 103, 'seriousNumAffected': 16}, {'id': 'EG001', 'title': 'Sildenafil', 'description': 'sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks', 'otherNumAtRisk': 113, 'otherNumAffected': 83, 'seriousNumAtRisk': 113, 'seriousNumAffected': 25}], 'otherEvents': [{'term': 'Angina Pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Atrial Flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Atrioventricular Block Second Degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Cardiac Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 5}], 'organSystem': 'Cardiac disorders'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 5}], 'organSystem': 'Cardiac disorders'}, {'term': 'Sinus Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 9}], 'organSystem': 'Vascular disorders'}, {'term': 'Hot Flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 2}], 'organSystem': 'Vascular disorders'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 0}], 'organSystem': 'Vascular disorders'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 1}], 'organSystem': 'Vascular disorders'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 8}], 'organSystem': 'Vascular disorders'}, {'term': 'Perhipheral Coldness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 1}], 'organSystem': 'Vascular disorders'}, {'term': 'Peripheral Ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 2}], 'organSystem': 'Vascular disorders'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 1}], 'organSystem': 'Vascular disorders'}, {'term': 'Varicose Vein', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 1}], 'organSystem': 'Vascular disorders'}, {'term': 'Balance Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 9}], 'organSystem': 'Nervous system disorders'}, {'term': 'Dizziness Postural', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 27}], 'organSystem': 'Nervous system disorders'}, {'term': 'Memory Impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Parosmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 2}], 'organSystem': 'Nervous system disorders'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Diarhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Tinnitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 3}], 'organSystem': 'Ear and labyrinth disorders'}, {'term': 'Visual Impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 7}], 'organSystem': 'Eye disorders'}, {'term': 'Non-Cardiac Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 0}], 'organSystem': 'General disorders'}], 'seriousEvents': [{'term': 'Acute Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Angina Pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Angina Unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Atrioventricular Block Second Degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Cardiac Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 9}], 'organSystem': 'Cardiac disorders'}, {'term': 'Cardiac Failure Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 2}], 'organSystem': 'Cardiac disorders'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Sinus Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Supraventricular Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Ventricular Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 0}], 'organSystem': 'Vascular disorders'}, {'term': 'Hypertensive Emergency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 0}], 'organSystem': 'Vascular disorders'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 1}], 'organSystem': 'Vascular disorders'}, {'term': 'Implant Site Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 4}], 'organSystem': 'Infections and infestations'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 113, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Exercise Capacity, as Determined by Peak Oxygen Uptake', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}, {'id': 'OG001', 'title': 'Sildenafil', 'description': 'sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.07', 'spread': '2.00', 'groupId': 'OG000'}, {'value': '-0.12', 'spread': '2.29', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to Week 24', 'unitOfMeasure': 'ml/min/kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed consisted of those participants who had the endpoint data available to be derived.'}, {'type': 'SECONDARY', 'title': 'Exercise Capacity, as Determined by Peak Oxygen Uptake', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}, {'id': 'OG001', 'title': 'Sildenafil', 'description': 'sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.02', 'spread': '1.70', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '2.20', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to Week 12', 'unitOfMeasure': 'ml/min/kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed consisted of those participants who had the endpoint data available to be derived.'}, {'type': 'SECONDARY', 'title': 'Exercise Capacity as Determined by Walk Distance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}, {'id': 'OG001', 'title': 'Sildenafil', 'description': 'sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '26.2', 'spread': '83.7', 'groupId': 'OG000'}, {'value': '5.2', 'spread': '69.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to Week 12', 'description': '6 Minute Walk Distance', 'unitOfMeasure': 'meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed consisted of those participants who had the endpoint data available to be derived.'}, {'type': 'SECONDARY', 'title': 'Composite Score Reflective of Clinical Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}, {'id': 'OG001', 'title': 'Sildenafil', 'description': 'sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '95.8', 'spread': '55.0', 'groupId': 'OG000'}, {'value': '94.2', 'spread': '54.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured at Week 24', 'description': 'Participants ranked sequentially with ranking stratified in one of three tiers based on:\n\n1. Death (lowest tier) The person with the shortest time from randomization to death is given the lowest rank within the tier.\n2. Hospitalizations due to cardiovascular or renal causes (middle tier) For patients alive, the ranking within this tier is based on time to hospitalization from randomization date. The person with the first cardiovascular or renal cause hospitalization will be given the lowest rank within the tier.\n3. Change in Minnesota Living with Heart Failure Questionnaire (MLWHFQ) from baseline (highest tier)\n\nThe use of three tiers within the ranking reflects the greater adverse impact of death or cardiovascular hospitalization on clinical status without an arbitrary assignment as to the relative value of these events in relation to changes in quality of life. Rank order: 1-189 (higher values are better)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed consisted of those participants who had the endpoint data available to be derived.'}, {'type': 'SECONDARY', 'title': 'Exercise Capacity as Determined by Walk Distance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}, {'id': 'OG001', 'title': 'Sildenafil', 'description': 'sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '17.5', 'spread': '88.6', 'groupId': 'OG000'}, {'value': '12.0', 'spread': '94.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to Week 24', 'description': '6 minute walk distance', 'unitOfMeasure': 'meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed consisted of those participants who had the endpoint data available to be derived.'}, {'type': 'SECONDARY', 'title': 'Cardiopulmonary Exercise Test (CPET) Duration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}, {'id': 'OG001', 'title': 'Sildenafil', 'description': 'sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.25', 'spread': '1.61', 'groupId': 'OG000'}, {'value': '-0.15', 'spread': '1.60', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to Week 12', 'description': 'To interpret the CPET Exercise Duration change endpoints, an increase in exercise duration between Baseline and Week 12/Week 24 is considered to be an improvement', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed consisted of those participants who had the endpoint data available to be derived.'}, {'type': 'SECONDARY', 'title': 'Cardiopulmonary Exercise Test (CPET) Duration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}, {'id': 'OG001', 'title': 'Sildenafil', 'description': 'sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '9.82', 'spread': '2.63', 'groupId': 'OG000'}, {'value': '9.77', 'spread': '3.21', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to Week 24', 'description': 'To interpret the CPET Exercise Duration change endpoints, an increase in exercise duration between Baseline and Week 12/Week 24 is considered to be an improvement', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed consisted of those participants who had the endpoint data available to be derived.'}, {'type': 'SECONDARY', 'title': 'Ventilatory Anaerobic Threshold', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}, {'id': 'OG001', 'title': 'Sildenafil', 'description': 'sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.01', 'spread': '1.14', 'groupId': 'OG000'}, {'value': '0.06', 'spread': '1.24', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to Week 12', 'description': 'To interpret the Ventilatory Anaerobic Threshold (VAT) change endpoints, an increase in VAT between Baseline and Week 12/Week 24 is considered to be an improvement', 'unitOfMeasure': 'ml/min/kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed consisted of those participants who had the endpoint data available to be derived.'}, {'type': 'SECONDARY', 'title': 'Ventilatory Anaerobic Threshold', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}, {'id': 'OG001', 'title': 'Sildenafil', 'description': 'sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.10', 'spread': '1.26', 'groupId': 'OG000'}, {'value': '0.17', 'spread': '1.26', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to Week 24', 'description': 'To interpret the Ventilatory Anaerobic Threshold (VAT) change endpoints, an increase in VAT between Baseline and Week 12/Week 24 is considered to be an improvement', 'unitOfMeasure': 'ml/min/kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed consisted of those participants who had the endpoint data available to be derived.'}, {'type': 'SECONDARY', 'title': 'Minnesota Living With Heart Failure Questionnaire (MLWHFQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}, {'id': 'OG001', 'title': 'Sildenafil', 'description': 'sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.3', 'spread': '22.0', 'groupId': 'OG000'}, {'value': '-6.2', 'spread': '20.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to Week 12', 'description': 'The MLWHFQ is a self-administered, disease-specific measure of health related quality of life (QOL) that assesses patients perceptions of the influence of heart failure on physical, socioeconomic and psychological aspects of life. Patients respond to 21 items using a six-point response scale (0-5). The total summary score can range from 0-105 with a lower score reflecting better heart failure related QOL. Two sub-scale scores reflect physical (8 items) and emotional (5 items) impairment.\n\nTotal score: 0 - 105 Physical subscore: 0 - 40 Emotional subscore: 0 - 25', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed consisted of those participants who had the endpoint data available to be derived.'}, {'type': 'SECONDARY', 'title': 'Minnesota Living With Heart Failure Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}, {'id': 'OG001', 'title': 'Sildenafil', 'description': 'sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-9.2', 'spread': '24.2', 'groupId': 'OG000'}, {'value': '-8.3', 'spread': '19.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to Week 24', 'description': 'The MLWHFQ is a self-administered, disease-specific measure of health related quality of life (QOL) that assesses patients perceptions of the influence of heart failure on physical, socioeconomic and psychological aspects of life. Patients respond to 21 items using a six-point response scale (0-5). The total summary score can range from 0-105 with a lower score reflecting better heart failure related QOL. Two sub-scale scores reflect physical (8 items) and emotional (5 items) impairment.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed consisted of those participants who had the endpoint data available to be derived.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'MRI Left Ventricular Mass', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}, {'id': 'OG001', 'title': 'Sildenafil', 'description': 'sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.29', 'spread': '14.43', 'groupId': 'OG000'}, {'value': '-0.07', 'spread': '14.93', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to Week 24', 'description': 'A decrease in LV Mass is considered an improvement', 'unitOfMeasure': 'gm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed consisted of those participants who had the endpoint data available to be derived.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'MRI Left Ventricular Mass Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}, {'id': 'OG001', 'title': 'Sildenafil', 'description': 'sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.47', 'spread': '6.54', 'groupId': 'OG000'}, {'value': '0.61', 'spread': '6.96', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to Week 24', 'description': 'A decrease in Left Ventricular Mass Index is considered an improvement', 'unitOfMeasure': 'gm/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed consisted of those participants who had the endpoint data available to be derived.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'MRI Left Ventricular End Diastolic Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}, {'id': 'OG001', 'title': 'Sildenafil', 'description': 'sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.70', 'spread': '21.03', 'groupId': 'OG000'}, {'value': '3.61', 'spread': '25.02', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to Week 24', 'description': 'An increase in Left Ventricular End Diastolic Volume is considered an improvement', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed consisted of those participants who had the endpoint data available to be derived.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'MRI Left Ventricular End Diastolic Volume Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}, {'id': 'OG001', 'title': 'Sildenafil', 'description': 'sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.73', 'spread': '9.45', 'groupId': 'OG000'}, {'value': '2.11', 'spread': '11.21', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to Week 24', 'description': 'An increase in Left Ventricular End Diastolic Volume Index is considered an improvement', 'unitOfMeasure': 'mL/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed consisted of those participants who had the endpoint data available to be derived.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'MRI Left Ventricular End Systolic Volume Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}, {'id': 'OG001', 'title': 'Sildenafil', 'description': 'sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.82', 'spread': '4.09', 'groupId': 'OG000'}, {'value': '0.25', 'spread': '6.12', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to Week 24', 'description': 'An increase in Left Ventricular End Systolic Volume Index is considered an improvement', 'unitOfMeasure': 'mL/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed consisted of those participants who had the endpoint data available to be derived.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'MRI Left Ventricular Ejection Fraction (LVEF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}, {'id': 'OG001', 'title': 'Sildenafil', 'description': 'sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.55', 'spread': '4.28', 'groupId': 'OG000'}, {'value': '0.62', 'spread': '4.88', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to Week 24', 'description': 'An increase in LVEF is considered an improvement', 'unitOfMeasure': 'percentage of volume', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed consisted of those participants who had the endpoint data available to be derived.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Echocardiogram Left Ventricular Mass', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}, {'id': 'OG001', 'title': 'Sildenafil', 'description': 'sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.93', 'spread': '47.36', 'groupId': 'OG000'}, {'value': '-8.79', 'spread': '35.60', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to Week 24', 'description': 'A decrease in Left Ventricular Mass is considered an improvement', 'unitOfMeasure': 'gm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed consisted of those participants who had the endpoint data available to be derived.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Medial Diastolic Elastance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}, {'id': 'OG001', 'title': 'Sildenafil', 'description': 'sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.10', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to Week 24', 'description': 'A decrease in Medial Diastolic Elastance is considered an improvement', 'unitOfMeasure': '(m/sec)/cc', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed consisted of those participants who had the endpoint data available to be derived.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Lateral Diastolic Elastance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}, {'id': 'OG001', 'title': 'Sildenafil', 'description': 'sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.00', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.08', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to Week 24', 'description': 'A decrease in Lateral Diastolic Elastance is considered an improvement', 'unitOfMeasure': '(m/sec)/cc', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed consisted of those participants who had the endpoint data available to be derived.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Medial Left Ventricular Relaxation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}, {'id': 'OG001', 'title': 'Sildenafil', 'description': 'sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.00', 'spread': '0.02', 'groupId': 'OG000'}, {'value': '-0.00', 'spread': '0.02', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to Week 24', 'description': 'An increase in Left Ventricular relaxation is considered to be an improvement', 'unitOfMeasure': 'm/sec', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed consisted of those participants who had the endpoint data available to be derived.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Lateral Left Ventricular Relaxation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'placebo 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'Placebo', 'description': 'placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}, {'id': 'OG001', 'title': 'Sildenafil', 'description': 'sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.64', 'spread': '6.83', 'groupId': 'OG000'}, {'value': '0.33', 'spread': '6.04', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to Week 24', 'description': 'A decrease in medial filling pressure is considered an improvement', 'unitOfMeasure': 'm/sec', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed consisted of those participants who had the endpoint data available to be derived.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Lateral Filling Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}, {'id': 'OG001', 'title': 'Sildenafil', 'description': 'sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.44', 'spread': '5.17', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': '5.68', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to Week 24', 'description': 'A decrease in lateral filling pressure is considered an improvement', 'unitOfMeasure': 'm/sec', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed consisted of those participants who had the endpoint data available to be derived.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'ECHO Effective Arterial Elastance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}, {'id': 'OG001', 'title': 'Sildenafil', 'description': 'sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.03', 'spread': '0.46', 'groupId': 'OG000'}, {'value': '-0.07', 'spread': '0.36', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to Week 24', 'description': 'A decrease in Effective Arterial Elastance is considered an improvement', 'unitOfMeasure': 'Farads-1', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed consisted of those participants who had the endpoint data available to be derived.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'ECHO Systemic Vascular Resistance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}, {'id': 'OG001', 'title': 'Sildenafil', 'description': 'sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.01', 'spread': '0.46', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.35', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to Week 24', 'description': 'A decrease in Systemic Vascular Resistance is considered an improvement', 'unitOfMeasure': 'Woods units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed consisted of those participants who had the endpoint data available to be derived.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'MRI Effective Arterial Elastance', 'denoms': [{'units': 'Participants', 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'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}, {'id': 'OG001', 'title': 'Sildenafil', 'description': 'sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.06', 'spread': '0.57', 'groupId': 'OG000'}, {'value': '-0.10', 'spread': '0.39', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to Week 24', 'description': 'A decrease in Systemic Vascular Resistance is considered an improvement', 'unitOfMeasure': 'Woods units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed consisted of those participants who had the endpoint data available to be derived.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'MRI Aortic Thickness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}, {'id': 'OG001', 'title': 'Sildenafil', 'description': 'sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.01', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '-0.03', 'spread': '0.18', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to Week 24', 'description': 'A decrease in Aortic Thickness is considered an improvement', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed consisted of those participants who had the endpoint data available to be derived.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'MRI Aortic Distensibility', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}, {'id': 'OG001', 'title': 'Sildenafil', 'description': 'sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.12', 'spread': '0.66', 'groupId': 'OG000'}, {'value': '0.29', 'spread': '1.13', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to Week 24', 'description': 'An increase in Aortic Distensibility is considered to be an improvement', 'unitOfMeasure': 'cm^2*dyne-1', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed consisted of those participants who had the endpoint data available to be derived.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'ECHO Pulmonary Artery Systolic Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}, {'id': 'OG001', 'title': 'Sildenafil', 'description': 'sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.15', 'spread': '12.43', 'groupId': 'OG000'}, {'value': '0.32', 'spread': '10.09', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to Week 24', 'description': 'A decrease in Pulmonary Artery Systolic Pressure is considered to be an improvement', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed consisted of those participants who had the endpoint data available to be derived.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Best Available Creatinine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}, {'id': 'OG001', 'title': 'Sildenafil', 'description': 'sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.02', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '0.09', 'spread': '0.29', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to Week 24', 'description': 'Best available=local lab results only when core lab results not available', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed consisted of those participants who had the endpoint data available to be derived.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Best Available Glomerular Filtration Rate (GFR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}, {'id': 'OG001', 'title': 'Sildenafil', 'description': 'sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.91', 'spread': '15.02', 'groupId': 'OG000'}, {'value': '-3.27', 'spread': '12.16', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to Week 24', 'description': 'Best available=local lab results when core lab results not available', 'unitOfMeasure': 'mL/min/1.73m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed consisted of those participants who had the endpoint data available to be derived.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Cystatin C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}, {'id': 'OG001', 'title': 'Sildenafil', 'description': 'sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.27', 'groupId': 'OG000'}, {'value': '0.10', 'spread': '0.29', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to Week 24', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed consisted of those participants who had the endpoint data available to be derived.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Uric Acid', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}, {'id': 'OG001', 'title': 'Sildenafil', 'description': 'sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.11', 'spread': '1.79', 'groupId': 'OG000'}, {'value': '0.51', 'spread': '1.80', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to Week 24', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed consisted of those participants who had the endpoint data available to be derived.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'N-terminal Pro B-type Natriuretic Peptide (NT Pro-BNP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}, {'id': 'OG001', 'title': 'Sildenafil', 'description': 'sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-50.52', 'spread': '799.87', 'groupId': 'OG000'}, {'value': '158.25', 'spread': '538.85', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to Week 24', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed consisted of those participants who had the endpoint data available to be derived.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Aldosterone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}, {'id': 'OG001', 'title': 'Sildenafil', 'description': 'sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '7.04', 'spread': '220.06', 'groupId': 'OG000'}, {'value': '1.22', 'spread': '213.47', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to Week 24', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed consisted of those participants who had the endpoint data available to be derived.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'High Sensitivity Troponin I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}, {'id': 'OG001', 'title': 'Sildenafil', 'description': 'sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '3.88', 'spread': '29.71', 'groupId': 'OG000'}, {'value': '11.11', 'spread': '62.49', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to Week 24', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed consisted of those participants who had the endpoint data available to be derived.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Procollagen III N-terminal Peptide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}, {'id': 'OG001', 'title': 'Sildenafil', 'description': 'sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.58', 'spread': '5.22', 'groupId': 'OG000'}, {'value': '0.41', 'spread': '3.90', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to Week 24', 'unitOfMeasure': 'ug/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed consisted of those participants who had the endpoint data available to be derived.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Endothelin-1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}, {'id': 'OG001', 'title': 'Sildenafil', 'description': 'sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.04', 'spread': '1.51', 'groupId': 'OG000'}, {'value': '0.49', 'spread': '1.29', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to Week 24', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed consisted of those participants who had the endpoint data available to be derived.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'High Sensitivity C-Reactive Protein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}, {'id': 'OG001', 'title': 'Sildenafil', 'description': 'sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.36', 'spread': '7.20', 'groupId': 'OG000'}, {'value': '0.32', 'spread': '5.49', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to Week 24', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed consisted of those participants who had the endpoint data available to be derived.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Collagen Type I (CITP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}, {'id': 'OG001', 'title': 'Sildenafil', 'description': 'sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.17', 'spread': '4.03', 'groupId': 'OG000'}, {'value': '5.61', 'spread': '48.96', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to Week 24', 'unitOfMeasure': 'ug/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed consisted of those participants who had the endpoint data available to be derived.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Cyclic Guanosine Monophosphate (cGMP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}, {'id': 'OG001', 'title': 'Sildenafil', 'description': 'sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '1.28', 'spread': '37.05', 'groupId': 'OG000'}, {'value': '8.72', 'spread': '30.22', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to Week 24', 'unitOfMeasure': 'pmol/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed consisted of those participants who had the endpoint data available to be derived.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Galectin 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}, {'id': 'OG001', 'title': 'Sildenafil', 'description': 'sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '1.10', 'spread': '9.63', 'groupId': 'OG000'}, {'value': '1.26', 'spread': '7.71', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to Week 24', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed consisted of those participants who had the endpoint data available to be derived.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Furosemide-Equivalent Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}, {'id': 'OG001', 'title': 'Sildenafil', 'description': 'sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.23', 'spread': '35.44', 'groupId': 'OG000'}, {'value': '7.27', 'spread': '59.53', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to Week 24', 'unitOfMeasure': 'mg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed consisted of those participants who had the endpoint data available to be derived.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}, {'id': 'FG001', 'title': 'Sildenafil', 'description': 'sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '103'}, {'groupId': 'FG001', 'numSubjects': '113'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '98'}, {'groupId': 'FG001', 'numSubjects': '101'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '12'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '216', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': '20 mg tid for 12 weeks followed by 60 mg tid for 12 weeks'}, {'id': 'BG001', 'title': 'Sildenafil', 'description': '20 mg tid for 12 weeks followed by 60 mg tid for 12 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.7', 'spread': '10.1', 'groupId': 'BG000'}, {'value': '68.4', 'spread': '10.5', 'groupId': 'BG001'}, {'value': '68.5', 'spread': '10.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '112', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '194', 'groupId': 'BG002'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 216}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-14', 'studyFirstSubmitDate': '2008-09-30', 'resultsFirstSubmitDate': '2013-04-04', 'studyFirstSubmitQcDate': '2008-09-30', 'lastUpdatePostDateStruct': {'date': '2014-07-23', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-07-02', 'studyFirstPostDateStruct': {'date': '2008-10-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-07-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'MRI Left Ventricular Mass', 'timeFrame': 'Change from Baseline to Week 24', 'description': 'A decrease in LV Mass is considered an improvement'}, {'measure': 'MRI Left Ventricular Mass Index', 'timeFrame': 'Change from Baseline to Week 24', 'description': 'A decrease in Left Ventricular Mass Index is considered an improvement'}, {'measure': 'MRI Left Ventricular End Diastolic Volume', 'timeFrame': 'Change from Baseline to Week 24', 'description': 'An increase in Left Ventricular End Diastolic Volume is considered an improvement'}, {'measure': 'MRI Left Ventricular End Diastolic Volume Index', 'timeFrame': 'Change from Baseline to Week 24', 'description': 'An increase in Left Ventricular End Diastolic Volume Index is considered an improvement'}, {'measure': 'MRI Left Ventricular End Systolic Volume Index', 'timeFrame': 'Change from Baseline to Week 24', 'description': 'An increase in Left Ventricular End Systolic Volume Index is considered an improvement'}, {'measure': 'MRI Left Ventricular Ejection Fraction (LVEF)', 'timeFrame': 'Change from Baseline to Week 24', 'description': 'An increase in LVEF is considered an improvement'}, {'measure': 'Echocardiogram Left Ventricular Mass', 'timeFrame': 'Change from Baseline to Week 24', 'description': 'A decrease in Left Ventricular Mass is considered an improvement'}, {'measure': 'Medial Diastolic Elastance', 'timeFrame': 'Change from Baseline to Week 24', 'description': 'A decrease in Medial Diastolic Elastance is considered an improvement'}, {'measure': 'Lateral Diastolic Elastance', 'timeFrame': 'Change from Baseline to Week 24', 'description': 'A decrease in Lateral Diastolic Elastance is considered an improvement'}, {'measure': 'Medial Left Ventricular Relaxation', 'timeFrame': 'Change from Baseline to Week 24', 'description': 'An increase in Left Ventricular relaxation is considered to be an improvement'}, {'measure': 'Lateral Left Ventricular Relaxation', 'timeFrame': 'Change from Baseline to Week 24', 'description': 'An increase in Left Ventricular relaxation is considered to be an improvement'}, {'measure': 'Medial Filling Pressure', 'timeFrame': 'Change from Baseline to Week 24', 'description': 'A decrease in medial filling pressure is considered an improvement'}, {'measure': 'Lateral Filling Pressure', 'timeFrame': 'Change from Baseline to Week 24', 'description': 'A decrease in lateral filling pressure is considered an improvement'}, {'measure': 'ECHO Effective Arterial Elastance', 'timeFrame': 'Change from Baseline to Week 24', 'description': 'A decrease in Effective Arterial Elastance is considered an improvement'}, {'measure': 'ECHO Systemic Vascular Resistance', 'timeFrame': 'Change from Baseline to Week 24', 'description': 'A decrease in Systemic Vascular Resistance is considered an improvement'}, {'measure': 'MRI Effective Arterial Elastance', 'timeFrame': 'Change from Baseline to Week 24', 'description': 'A decrease in Effective Arterial Elastance is considered an improvement'}, {'measure': 'MRI Systemic Vascular Resistance', 'timeFrame': 'Change from Baseline to Week 24', 'description': 'A decrease in Systemic Vascular Resistance is considered an improvement'}, {'measure': 'MRI Aortic Thickness', 'timeFrame': 'Change from Baseline to Week 24', 'description': 'A decrease in Aortic Thickness is considered an improvement'}, {'measure': 'MRI Aortic Distensibility', 'timeFrame': 'Change from Baseline to Week 24', 'description': 'An increase in Aortic Distensibility is considered to be an improvement'}, {'measure': 'ECHO Pulmonary Artery Systolic Pressure', 'timeFrame': 'Change from Baseline to Week 24', 'description': 'A decrease in Pulmonary Artery Systolic Pressure is considered to be an improvement'}, {'measure': 'Best Available Creatinine', 'timeFrame': 'Change from Baseline to Week 24', 'description': 'Best available=local lab results only when core lab results not available'}, {'measure': 'Best Available Glomerular Filtration Rate (GFR)', 'timeFrame': 'Change from Baseline to Week 24', 'description': 'Best available=local lab results when core lab results not available'}, {'measure': 'Cystatin C', 'timeFrame': 'Change from Baseline to Week 24'}, {'measure': 'Uric Acid', 'timeFrame': 'Change from Baseline to Week 24'}, {'measure': 'N-terminal Pro B-type Natriuretic Peptide (NT Pro-BNP)', 'timeFrame': 'Change from Baseline to Week 24'}, {'measure': 'Aldosterone', 'timeFrame': 'Change from Baseline to Week 24'}, {'measure': 'High Sensitivity Troponin I', 'timeFrame': 'Change from Baseline to Week 24'}, {'measure': 'Procollagen III N-terminal Peptide', 'timeFrame': 'Change from Baseline to Week 24'}, {'measure': 'Endothelin-1', 'timeFrame': 'Change from Baseline to Week 24'}, {'measure': 'High Sensitivity C-Reactive Protein', 'timeFrame': 'Change from Baseline to Week 24'}, {'measure': 'Collagen Type I (CITP)', 'timeFrame': 'Change from Baseline to Week 24'}, {'measure': 'Cyclic Guanosine Monophosphate (cGMP)', 'timeFrame': 'Change from Baseline to Week 24'}, {'measure': 'Galectin 3', 'timeFrame': 'Change from Baseline to Week 24'}, {'measure': 'Furosemide-Equivalent Dose', 'timeFrame': 'Change from Baseline to Week 24'}], 'primaryOutcomes': [{'measure': 'Exercise Capacity, as Determined by Peak Oxygen Uptake', 'timeFrame': 'Change from Baseline to Week 24'}], 'secondaryOutcomes': [{'measure': 'Exercise Capacity, as Determined by Peak Oxygen Uptake', 'timeFrame': 'Change from Baseline to Week 12'}, {'measure': 'Exercise Capacity as Determined by Walk Distance', 'timeFrame': 'Change from Baseline to Week 12', 'description': '6 Minute Walk Distance'}, {'measure': 'Composite Score Reflective of Clinical Status', 'timeFrame': 'Measured at Week 24', 'description': 'Participants ranked sequentially with ranking stratified in one of three tiers based on:\n\n1. Death (lowest tier) The person with the shortest time from randomization to death is given the lowest rank within the tier.\n2. Hospitalizations due to cardiovascular or renal causes (middle tier) For patients alive, the ranking within this tier is based on time to hospitalization from randomization date. The person with the first cardiovascular or renal cause hospitalization will be given the lowest rank within the tier.\n3. Change in Minnesota Living with Heart Failure Questionnaire (MLWHFQ) from baseline (highest tier)\n\nThe use of three tiers within the ranking reflects the greater adverse impact of death or cardiovascular hospitalization on clinical status without an arbitrary assignment as to the relative value of these events in relation to changes in quality of life. Rank order: 1-189 (higher values are better)'}, {'measure': 'Exercise Capacity as Determined by Walk Distance', 'timeFrame': 'Change from Baseline to Week 24', 'description': '6 minute walk distance'}, {'measure': 'Cardiopulmonary Exercise Test (CPET) Duration', 'timeFrame': 'Change from Baseline to Week 12', 'description': 'To interpret the CPET Exercise Duration change endpoints, an increase in exercise duration between Baseline and Week 12/Week 24 is considered to be an improvement'}, {'measure': 'Cardiopulmonary Exercise Test (CPET) Duration', 'timeFrame': 'Change from Baseline to Week 24', 'description': 'To interpret the CPET Exercise Duration change endpoints, an increase in exercise duration between Baseline and Week 12/Week 24 is considered to be an improvement'}, {'measure': 'Ventilatory Anaerobic Threshold', 'timeFrame': 'Change from Baseline to Week 12', 'description': 'To interpret the Ventilatory Anaerobic Threshold (VAT) change endpoints, an increase in VAT between Baseline and Week 12/Week 24 is considered to be an improvement'}, {'measure': 'Ventilatory Anaerobic Threshold', 'timeFrame': 'Change from Baseline to Week 24', 'description': 'To interpret the Ventilatory Anaerobic Threshold (VAT) change endpoints, an increase in VAT between Baseline and Week 12/Week 24 is considered to be an improvement'}, {'measure': 'Minnesota Living With Heart Failure Questionnaire (MLWHFQ)', 'timeFrame': 'Change from Baseline to Week 12', 'description': 'The MLWHFQ is a self-administered, disease-specific measure of health related quality of life (QOL) that assesses patients perceptions of the influence of heart failure on physical, socioeconomic and psychological aspects of life. Patients respond to 21 items using a six-point response scale (0-5). The total summary score can range from 0-105 with a lower score reflecting better heart failure related QOL. Two sub-scale scores reflect physical (8 items) and emotional (5 items) impairment.\n\nTotal score: 0 - 105 Physical subscore: 0 - 40 Emotional subscore: 0 - 25'}, {'measure': 'Minnesota Living With Heart Failure Questionnaire', 'timeFrame': 'Change from Baseline to Week 24', 'description': 'The MLWHFQ is a self-administered, disease-specific measure of health related quality of life (QOL) that assesses patients perceptions of the influence of heart failure on physical, socioeconomic and psychological aspects of life. Patients respond to 21 items using a six-point response scale (0-5). The total summary score can range from 0-105 with a lower score reflecting better heart failure related QOL. Two sub-scale scores reflect physical (8 items) and emotional (5 items) impairment.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Heart Failure, Diastolic', 'Decompensated Heart Failure', 'Sildenafil', 'Exercise Capacity'], 'conditions': ['Heart Failure']}, 'referencesModule': {'references': [{'pmid': '23478662', 'type': 'RESULT', 'citation': "Redfield MM, Chen HH, Borlaug BA, Semigran MJ, Lee KL, Lewis G, LeWinter MM, Rouleau JL, Bull DA, Mann DL, Deswal A, Stevenson LW, Givertz MM, Ofili EO, O'Connor CM, Felker GM, Goldsmith SR, Bart BA, McNulty SE, Ibarra JC, Lin G, Oh JK, Patel MR, Kim RJ, Tracy RP, Velazquez EJ, Anstrom KJ, Hernandez AF, Mascette AM, Braunwald E; RELAX Trial. Effect of phosphodiesterase-5 inhibition on exercise capacity and clinical status in heart failure with preserved ejection fraction: a randomized clinical trial. JAMA. 2013 Mar 27;309(12):1268-77. doi: 10.1001/jama.2013.2024."}, {'pmid': '38533961', 'type': 'DERIVED', 'citation': 'Chiu L, Agrawal V, Armstrong D, Brittain E, Collins S, Hemnes AR, Hill JA, Lindenfeld J, Shah SJ, Stevenson LW, Wang TJ, Gupta DK. Correlates of Plasma NT-proBNP/Cyclic GMP Ratio in Heart Failure With Preserved Ejection Fraction: An Analysis of the RELAX Trial. J Am Heart Assoc. 2024 Apr 2;13(7):e031796. doi: 10.1161/JAHA.123.031796. Epub 2024 Mar 27.'}, {'pmid': '35358904', 'type': 'DERIVED', 'citation': 'Bevan GH, Rana M, Al-Furaih N, Dalton J, Zidar DA, Al-Kindi SG. Anisocytosis is associated with myocardial fibrosis and exercise capacity in heart failure with preserved ejection fraction. Heart Lung. 2022 Jul-Aug;54:68-73. doi: 10.1016/j.hrtlng.2022.03.013. Epub 2022 Mar 28.'}, {'pmid': '32150314', 'type': 'DERIVED', 'citation': 'Reddy YNV, Rikhi A, Obokata M, Shah SJ, Lewis GD, AbouEzzedine OF, Dunlay S, McNulty S, Chakraborty H, Stevenson LW, Redfield MM, Borlaug BA. Quality of life in heart failure with preserved ejection fraction: importance of obesity, functional capacity, and physical inactivity. Eur J Heart Fail. 2020 Jun;22(6):1009-1018. doi: 10.1002/ejhf.1788. Epub 2020 Mar 9.'}, {'pmid': '31805424', 'type': 'DERIVED', 'citation': 'Fudim M, Kelly JP, Jones AD, AbouEzzeddine OF, Ambrosy AP, Greene SJ, Reddy YNV, Anstrom KJ, Alhanti B, Lewis GD, Hernandez AF, Felker GM. Are existing and emerging biomarkers associated with cardiorespiratory fitness in patients with chronic heart failure? Am Heart J. 2020 Feb;220:97-107. doi: 10.1016/j.ahj.2019.11.006. Epub 2019 Nov 16.'}, {'pmid': '31272568', 'type': 'DERIVED', 'citation': 'Reddy YNV, Lewis GD, Shah SJ, Obokata M, Abou-Ezzedine OF, Fudim M, Sun JL, Chakraborty H, McNulty S, LeWinter MM, Mann DL, Stevenson LW, Redfield MM, Borlaug BA. Characterization of the Obese Phenotype of Heart Failure With Preserved Ejection Fraction: A RELAX Trial Ancillary Study. Mayo Clin Proc. 2019 Jul;94(7):1199-1209. doi: 10.1016/j.mayocp.2018.11.037.'}, {'pmid': '28214792', 'type': 'DERIVED', 'citation': 'AbouEzzeddine OF, McKie PM, Dunlay SM, Stevens SR, Felker GM, Borlaug BA, Chen HH, Tracy RP, Braunwald E, Redfield MM. Suppression of Tumorigenicity 2 in Heart Failure With Preserved Ejection Fraction. J Am Heart Assoc. 2017 Feb 18;6(2):e004382. doi: 10.1161/JAHA.116.004382.'}, {'pmid': '28194841', 'type': 'DERIVED', 'citation': 'DeVore AD, McNulty S, Alenezi F, Ersboll M, Vader JM, Oh JK, Lin G, Redfield MM, Lewis G, Semigran MJ, Anstrom KJ, Hernandez AF, Velazquez EJ. Impaired left ventricular global longitudinal strain in patients with heart failure with preserved ejection fraction: insights from the RELAX trial. Eur J Heart Fail. 2017 Jul;19(7):893-900. doi: 10.1002/ejhf.754. Epub 2017 Feb 14.'}, {'pmid': '27072860', 'type': 'DERIVED', 'citation': 'Hussain I, Mohammed SF, Forfia PR, Lewis GD, Borlaug BA, Gallup DS, Redfield MM. Impaired Right Ventricular-Pulmonary Arterial Coupling and Effect of Sildenafil in Heart Failure With Preserved Ejection Fraction: An Ancillary Analysis From the Phosphodiesterase-5 Inhibition to Improve Clinical Status And Exercise Capacity in Diastolic Heart Failure (RELAX) Trial. Circ Heart Fail. 2016 Apr;9(4):e002729. doi: 10.1161/CIRCHEARTFAILURE.115.002729.'}, {'pmid': '25104521', 'type': 'DERIVED', 'citation': 'Lindman BR, Davila-Roman VG, Mann DL, McNulty S, Semigran MJ, Lewis GD, de las Fuentes L, Joseph SM, Vader J, Hernandez AF, Redfield MM. Cardiovascular phenotype in HFpEF patients with or without diabetes: a RELAX trial ancillary study. J Am Coll Cardiol. 2014 Aug 12;64(6):541-9. doi: 10.1016/j.jacc.2014.05.030.'}, {'pmid': '24833648', 'type': 'DERIVED', 'citation': 'Mohammed SF, Borlaug BA, McNulty S, Lewis GD, Lin G, Zakeri R, Semigran MJ, LeWinter M, Hernandez AF, Braunwald E, Redfield MM. Resting ventricular-vascular function and exercise capacity in heart failure with preserved ejection fraction: a RELAX trial ancillary study. Circ Heart Fail. 2014 Jul;7(4):580-9. doi: 10.1161/CIRCHEARTFAILURE.114.001192. Epub 2014 May 15.'}, {'pmid': '24162898', 'type': 'DERIVED', 'citation': 'Zakeri R, Borlaug BA, McNulty SE, Mohammed SF, Lewis GD, Semigran MJ, Deswal A, LeWinter M, Hernandez AF, Braunwald E, Redfield MM. Impact of atrial fibrillation on exercise capacity in heart failure with preserved ejection fraction: a RELAX trial ancillary study. Circ Heart Fail. 2014 Jan;7(1):123-30. doi: 10.1161/CIRCHEARTFAILURE.113.000568. Epub 2013 Oct 25.'}, {'pmid': '22991405', 'type': 'DERIVED', 'citation': 'Redfield MM, Borlaug BA, Lewis GD, Mohammed SF, Semigran MJ, Lewinter MM, Deswal A, Hernandez AF, Lee KL, Braunwald E; Heart Failure Clinical Research Network. PhosphdiesteRasE-5 Inhibition to Improve CLinical Status and EXercise Capacity in Diastolic Heart Failure (RELAX) trial: rationale and design. Circ Heart Fail. 2012 Sep 1;5(5):653-9. doi: 10.1161/CIRCHEARTFAILURE.112.969071.'}]}, 'descriptionModule': {'briefSummary': 'Diastolic heart failure (DHF), which affects older individuals and women at a disproportionate rate, is a condition that can lead to shortness of breath and fluid build-up in the lungs. This study will evaluate the effectiveness of the medication sildenafil at improving exercise ability and health outcomes in people with DHF.', 'detailedDescription': 'DHF is a condition in which one of the chambers of the heart, the left ventricle, loses its ability to relax completely because the muscle has become too stiff. When this occurs, the heart is unable to properly fill with blood, which can lead to decreased blood circulation. People with DHF may experience shortness of breath and pulmonary congestion, which is an abnormal build-up of fluid in the lungs. Current treatment for DHF includes guidelines/recommendations to lower blood pressure, stop smoking, and lose weight, but there are no medications available to specifically treat DHF. Sildenafil, commonly known as Revatio or Viagra, is a medication that increases the supply of blood to the lungs and reduces the workload of the heart. Preliminary studies have shown that sildenafil may be beneficial at improving heart and lung function in people with DHF, but more research is needed to confirm these findings. The purpose of this study is to determine if sildenafil can improve exercise ability and health outcomes in people with DHF.\n\nThis 24-week study will enroll people with DHF. Participants will be randomly assigned to receive either sildenafil or placebo three times a day for 24 weeks. Participants will attend study visits at baseline and Weeks 1, 4, 12, 13, and 24. At most study visits, the following procedures will occur: physical exam, medical history review, questionnaires, blood collection, 6-minute walk test to measure endurance, and an exercise test. At baseline and Week 24, participants will also undergo an electrocardiogram, which will measure the electrical activity of the heart, and a cardiac magnetic resonance imaging (MRI) procedure and an echocardiogram, which will both obtain pictures of the heart. At Weeks 3, 8, 16, and 20, study researchers will call participants to collect health information.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Previous clinical diagnosis of heart failure with current New York Heart Association (NYHA) Class II-IV symptoms\n* Has experienced at least one of the following in the 12 months before study entry:\n\n * Hospitalization for decompensated heart failure\n * Acute treatment with intravenous loop diuretic or hemofiltration\n * Mean pulmonary capillary wedge pressure greater than 15 mm Hg or left ventricular end diastolic pressure (LVEDP) greater than 18 mm Hg at catheterization for dyspnea\n * Long term treatment with a loop diuretic and chronic diastolic dysfunction on echocardiography, as determined by left atrial enlargement\n* Left ventricular ejection fraction greater than or equal to 50%, as determined by a clinical echocardiogram or ventriculogram in the 12 months before study entry\n* Receiving stable medical therapy in the 30 days before study entry, as determined by no addition or removal of angiotensin converting enzyme inhibitor (ACE), angiotensin receptor blocker (ARB), beta-blockers, or calcium channel blockers (CCB) and no change in dosage of ACE, ARBs, beta-blockers, or CCBs of more than 100%\n\nExclusion Criteria:\n\n* Has a neuromuscular, orthopedic, or other non-cardiac condition that prevents individual from exercise testing on a bicycle ergometer or from walking in a hallway\n* Non-cardiac condition that limits life expectancy to less than 1 year at the time of study entry, based on the judgment of the physician\n* Current or anticipated future need for nitrate therapy\n* Valve disease (i.e., greater than mild aortic or mitral stenosis; greater than moderate aortic or mitral regurgitation)\n* Hypertrophic cardiomyopathy\n* Infiltrative or inflammatory myocardial disease (e.g., amyloid, sarcoid)\n* Pericardial disease\n* Primary pulmonary arteriopathy\n* Has experienced a heart attack or unstable angina, or has undergone percutaneous transluminal coronary angiography (PTCA) or coronary artery bypass grafting (CABG) in the 60 days before study entry, or requires either PTCA or CABG at the time of study entry\n* Other clinically important causes of dyspnea, such as morbid obesity or significant lung disease, as defined by clinical judgment or use of steroids or oxygen for lung disease\n* Systolic blood pressure less than 110 mm Hg or greater than 180 mm Hg\n* Diastolic blood pressure less than 40 mm Hg or greater than 100 mm Hg\n* Resting heart rate (HR) greater than 100 bpm\n* History of reduced ejection fraction (less than 50%)\n* Implanted metallic device that will interfere with MRI examination (in people without atrial fibrillation)\n* Severe kidney dysfunction (estimated glomerular filtration rate \\[GFR\\] less than 20 ml/min/1.73m2 by modified modification of diet in renal disease \\[MDRD\\] equation)\n* Pregnant or not using an effective form of contraception\n* Hemoglobin level of less than 10 g/dL\n* Taking alpha antagonists or cytochrome P450 3A4 inhibitors (e.g., ketoconazole, itraconazole, erythromycin, saquinavir, cimetidine, or serum protease inhibitors for HIV)\n* Retinitis pigmentosa, previous diagnosis of nonischemic optic neuropathy, untreated proliferative retinopathy, or unexplained visual disturbance\n* Sickle cell anemia, multiple myeloma, leukemia, or penile deformities that increase the risk for priapism (e.g., angulation, cavernosal fibrosis, Peyronie's disease)\n* Severe liver disease (aspartate aminotransferase \\[AST\\] level greater than three times the normal limit, alkaline phosphatase or bilirubin greater than two times the normal limit)\n* In being consistent with American College of Cardiology (ACC)/American Heart Association (AHA) guidelines, people with dyspnea and risk factors for coronary artery disease should have had a stress test and those people with a clinically indicated stress test demonstrating significant ischemia in the 1 year before study entry will be excluded.\n* Listed for heart transplantation"}, 'identificationModule': {'nctId': 'NCT00763867', 'acronym': 'RELAX', 'briefTitle': 'Evaluating the Effectiveness of Sildenafil at Improving Health Outcomes and Exercise Ability in People With Diastolic Heart Failure (The RELAX Study)', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Phosphodiesterase-5 Inhibition to Improve Clinical Status and Exercise Capacity in Diastolic Heart Failure (RELAX)', 'orgStudyIdInfo': {'id': 'Pro00018007'}, 'secondaryIdInfos': [{'id': 'U01HL084904', 'link': 'https://reporter.nih.gov/quickSearch/U01HL084904', 'type': 'NIH'}, {'id': 'U01HL084904-01', 'link': 'https://reporter.nih.gov/quickSearch/U01HL084904-01', 'type': 'NIH'}, {'id': '521'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Sildenafil', 'description': 'Sildenafil 20 mg three tid for 12 weeks followed by 60 mg tid for 12 weeks', 'interventionNames': ['Drug: Sildenafil']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Sugar pill to mimic Sildenafil'], 'armGroupLabels': ['Placebo']}, {'name': 'Sildenafil', 'type': 'DRUG', 'otherNames': ['Active Sildenafil'], 'armGroupLabels': ['Sildenafil']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85054', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic Arizona', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '30310', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Morehouse School of Medicine', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55415', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minnesota Heart Failure Network', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84107', 'city': 'Murray', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah Health Sciences Center', 'geoPoint': {'lat': 40.66689, 'lon': -111.88799}}, {'zip': '05401', 'city': 'Burlington', 'state': 'Vermont', 'country': 'United States', 'facility': 'University of Vermont - Fletcher Allen Health Care', 'geoPoint': {'lat': 44.47588, 'lon': -73.21207}}, {'zip': 'H1T - 1C8', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Montreal Heart Institute', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Kerry L. Lee, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke Clinical Research Institute'}, {'name': 'Eugene Braunwald, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Harvard University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}, {'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}