Viewing Study NCT03015402

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Ignite Creation Date: 2025-12-25 @ 3:54 AM
Ignite Modification Date: 2026-03-06 @ 1:34 PM
Study NCT ID: NCT03015402
Status: COMPLETED
Last Update Posted: 2024-06-07
First Post: 2017-01-05
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: Oral Nitrite in Patients With Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-04-11', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012977', 'term': 'Sodium Nitrite'}], 'ancestors': [{'id': 'D009573', 'term': 'Nitrites'}, {'id': 'D009608', 'term': 'Nitrous Acid'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'risbanomg@upmc.edu', 'phone': '412-692-2210', 'title': 'Dr. Michael Risbano, Director of Advanced Cardiopulmonary Exercise Testing Program', 'organization': 'University of Pittsburgh'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'This was a small clinical trial that under-enrolled due to the pandemic.'}}, 'adverseEventsModule': {'timeFrame': 'From Baseline through study completion, up to 26 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Oral Nitrite', 'description': 'Participants who received Oral Nitrite in the first or last 10 weeks of the study.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 22, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Participants who received placebo in the first or last 10 weeks of the study.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 23, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Heartburn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hand,Food, and mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Inflammation Right Ear', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Volume Overload', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest Tightness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Systolic Murmur', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness/Lightheadedness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Earache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Inflammation of Ear', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vision Disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Conjuctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Swelling of Extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'SARS-CoV-2 Virus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abscess of tooth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cramps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased Potassium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cirrhosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Joint Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gout Flare', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscle Strain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Shortness of breath', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased Respiratory Rate', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bibasilar Crackles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest Cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stent Procedure (leg)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Pulmonary Artery Pressure (mPAP) During Submaximal Exercise as Compared Between Placebo and Nitrite', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Nitrite', 'description': 'Participants who received Oral Nitrite in the first or last 10 weeks of the study.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants who received placebo in the first or last 10 weeks of the study.'}], 'classes': [{'title': 'Supine Mean Pulmonary Artery Pressure at Baseline', 'categories': [{'measurements': [{'value': '48.75', 'spread': '11.73', 'groupId': 'OG000'}, {'value': '48.68', 'spread': '11.34', 'groupId': 'OG001'}]}]}, {'title': 'Supine Mean Pulmonary Artery Pressure at 10 Weeks', 'categories': [{'measurements': [{'value': '56.81', 'spread': '9.87', 'groupId': 'OG000'}, {'value': '55.0', 'spread': '8.10', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.20', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Pre-randomization characteristics of 2 groups will be presented using the median (IQR) or frequency tables at each study sequence. The difference of mPAP during submax exercise compared between placebo and nitrite at 10 weeks (i.e. week 10 RHC of placebo vs week 10 RHC of nitrite) using parametric PK-cross analysis (i.e. ANOVA to determine the sequence, period, carryover, \\& treatment effects). Post-exercise values before \\& after crossover will be compared between 2 groups using similar approach.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 10 weeks', 'description': 'Mean Pulmonary Artery Pressure measurement at submaximal exercise as compared between Placebo and Oral Nitrite at 10 weeks.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of each intervention and completed all study visits were included in the efficacy analysis.'}, {'type': 'SECONDARY', 'title': 'Difference in 6-minute Walk Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Nitrite', 'description': 'Participants who received Oral Nitrite in the first or last 10 weeks of the study.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants who received placebo in the first or last 10 weeks of the study.'}], 'classes': [{'title': 'Baseline Distance', 'categories': [{'measurements': [{'value': '269.5', 'spread': '130.3', 'groupId': 'OG000'}, {'value': '253.2', 'spread': '59.7', 'groupId': 'OG001'}]}]}, {'title': '10 Weeks Distance', 'categories': [{'measurements': [{'value': '267.6', 'spread': '164.1', 'groupId': 'OG000'}, {'value': '255.2', 'spread': '89.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 10 weeks', 'description': 'The 6-minute walk test measures the distance an individual is able to walk over 6 minutes on a hard, flat surface. The subject is allowed to self-pace and rest as needed.\n\nThe number of subjects with available 6-minute walk tests do not match the total number of subjects in the study due to: one subject fracturing a foot and several subjects missing visit timepoints due to health issues resulting in 6 minute walk test not being performed.', 'unitOfMeasure': 'meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of each intervention and completed all study visits were included in the efficacy analysis.'}, {'type': 'SECONDARY', 'title': 'Change in Right Heart Catheterization (RHC) Hemodynamics - Pulmonary Capillary Wedge Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Nitrite', 'description': 'Participants who received Oral Nitrite in the first or last 10 weeks of the study.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants who received placebo in the first or last 10 weeks of the study.'}], 'classes': [{'title': 'Pulmonary Capillary Wedge Pressure (Rest)', 'categories': [{'measurements': [{'value': '28.2', 'spread': '8.7', 'groupId': 'OG000'}, {'value': '26.3', 'spread': '7.9', 'groupId': 'OG001'}]}]}, {'title': 'Pulmonary Capillary Wedge Pressure (Exercise)', 'categories': [{'measurements': [{'value': '29.9', 'spread': '11.8', 'groupId': 'OG000'}, {'value': '28.4', 'spread': '10.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During Week 10 follow-up at rest and at exercise', 'description': 'Right heart catheterization hemodynamic measures will be aggregated to determine if overall hemodynamic on Pulmonary Capillary Wedge Pressure are improved over the course of treatment.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of each intervention and completed all study visits were included in the efficacy analysis.'}, {'type': 'SECONDARY', 'title': 'Change in Severity of Heart Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Nitrite', 'description': 'Participants who received Oral Nitrite in the first or last 10 weeks of the study.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants who received placebo in the first or last 10 weeks of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '4146.055', 'spread': '3357.261', 'groupId': 'OG000'}, {'value': '4215.096', 'spread': '3372.754', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 10', 'description': 'Determined by N-terminal pro b-type natriuretic peptide (NT-proBNP) plasma levels.\n\nThe number of subjects with available NT-proBNP values do not match the total number in the study as several subjects missed visit timepoints due to health issues resulting in NT-proBNP not being obtained.', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of each intervention and completed all study visits were included in the efficacy analysis.'}, {'type': 'SECONDARY', 'title': 'Change in Right Heart Catheterization (RHC) Hemodynamics - Trans Pulmonary Gradient', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Nitrite', 'description': 'Participants who received Oral Nitrite in the first or last 10 weeks of the study.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants who received placebo in the first or last 10 weeks of the study.'}], 'classes': [{'title': 'Trans Pulmonary Gradient (Rest)', 'categories': [{'measurements': [{'value': '20.6', 'spread': '12.1', 'groupId': 'OG000'}, {'value': '22.6', 'spread': '11.1', 'groupId': 'OG001'}]}]}, {'title': 'Trans Pulmonary Gradient (Exercise)', 'categories': [{'measurements': [{'value': '27.1', 'spread': '11.2', 'groupId': 'OG000'}, {'value': '26.6', 'spread': '8.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During Week 10 follow-up at rest and at exercise', 'description': 'Right heart catheterization hemodynamic measures will be aggregated to determine if overall hemodynamic on Trans Pulmonary Gradient are improved over the course of treatment.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Right Heart Catheterization (RHC) Hemodynamics - Pulmonary Vascular Resistance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Nitrite', 'description': 'Participants who received Oral Nitrite in the first or last 10 weeks of the study.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants who received placebo in the first or last 10 weeks of the study.'}], 'classes': [{'title': 'Pulmonary Vascular Resistance (Rest)', 'categories': [{'measurements': [{'value': '3.2', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '2.5', 'groupId': 'OG001'}]}]}, {'title': 'Pulmonary Vascular Resistance (Exercise)', 'categories': [{'measurements': [{'value': '3.4', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '1.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During Week 10 follow-up at rest and at exercise', 'description': 'Right heart catheterization hemodynamic measures will be aggregated to determine if overall hemodynamic on Pulmonary Vascular Resistance are improved over the course of treatment.', 'unitOfMeasure': 'Wood Units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of each intervention and completed all study visits were included in the efficacy analysis.'}, {'type': 'SECONDARY', 'title': 'Change in Right Heart Catheterization (RHC) Hemodynamics - Cardiac Output', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Nitrite', 'description': 'Participants who received Oral Nitrite in the first or last 10 weeks of the study.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants who received placebo in the first or last 10 weeks of the study.'}], 'classes': [{'title': 'Cardiac Output (Rest)', 'categories': [{'measurements': [{'value': '8.1', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '8.8', 'spread': '3.1', 'groupId': 'OG001'}]}]}, {'title': 'Cardiac Output (Exercise)', 'categories': [{'measurements': [{'value': '9.4', 'spread': '3.1', 'groupId': 'OG000'}, {'value': '10', 'spread': '3.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During Week 10 follow-up at rest and at exercise', 'description': 'Right heart catheterization hemodynamic measures will be aggregated to determine if overall hemodynamic on Cardiac Output are improved over the course of treatment.', 'unitOfMeasure': 'liters per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of each intervention and completed all study visits were included in the efficacy analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Different Severities of Heart Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Nitrite', 'description': 'Participants who received Oral Nitrite in the first or last 10 weeks of the study.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants who received placebo in the first or last 10 weeks of the study.'}], 'classes': [{'title': 'Class I', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Class II', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Class III', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Class IV', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '10 weeks', 'description': 'Determined by NYHA functional classification changes. Class I - No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc.\n\nClass II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity.\n\nClass III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100 m). Comfortable only at rest.\n\nClass IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.\n\nWhile the change in severity of heart failure is listed as an end point, since this is ordinal data we cannot provide a p-value. We present the NYHA data at screening, crossover and 10 weeks.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of each intervention and completed all study visits were included in the efficacy analysis.\n\nNot all subjects had NYHA Functional class assessed as some subjects missed appointments and some were lost due to the pandemic.'}, {'type': 'SECONDARY', 'title': 'Change in Endurance Exercise Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nitrite', 'description': 'Participants who received Oral Nitrite in the first or last 10 weeks of the study.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants who received placebo in the first or last 10 weeks of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.056', 'spread': '2.526', 'groupId': 'OG000'}, {'value': '-0.904', 'spread': '3.705', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 weeks', 'description': 'The endurance exercise time will be measured from the start of loaded pedaling to volitional exhaustion and the worklaod has returned to unloaded pedaling.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of each intervention and completed all study visits were included in the efficacy analysis.\n\nThis value represents the change in endurance time (difference in time measured while pedaling) from baseline to week 10 during cardiopulmonary exercise testing in minutes.\n\nNot all subjects had cardiopulmonary exercise testing performed due to missed visits related to personal health (i.e. fracture, or not feeling well to travel).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Nitrite Then Placebo', 'description': 'Sodium Nitrite: 40 mg PO (by mouth) TID (three times each day) for 10 weeks, then crossover to receive placebo for 10 weeks.'}, {'id': 'FG001', 'title': 'Placebo Then Nitrite', 'description': 'Placebo Oral Capsule: Placebo capsule that is of identical size, shape, and color to experimental drug capsule PO (by mouth) TID (three times each day) for 10 weeks, then crossover to receive nitrite for 10 weeks.'}], 'periods': [{'title': 'First Intervention (10 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}, {'title': 'Washout (2 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'comment': '2 withdrew prior to the start of the washout period.', 'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention (10 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'A total of 33 subjects were enrolled and consented with 9 screen failed/ineligible and 24 randomized. Of the 24 randomized, 3 were on drug/placebo but withdrew at a later time, and 21 completed the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Nitrite Then Placebo', 'description': 'Sodium Nitrite: 40 mg PO (by mouth) TID (three times each day) for 10 weeks, then crossover to receive placebo for 10 weeks.'}, {'id': 'BG001', 'title': 'Placebo Then Nitrite', 'description': 'Placebo Oral Capsule: Placebo capsule that is of identical size, shape, and color to experimental drug capsule PO (by mouth) TID (three times each day) for 10 weeks, then crossover to receive nitrite for 10 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69.3', 'spread': '7.0', 'groupId': 'BG000'}, {'value': '69.6', 'spread': '7.4', 'groupId': 'BG001'}, {'value': '69.4', 'spread': '7.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sitting Systolic Blood Pressure', 'classes': [{'categories': [{'measurements': [{'value': '138', 'spread': '17.4', 'groupId': 'BG000'}, {'value': '131.5', 'spread': '17.1', 'groupId': 'BG001'}, {'value': '134.7', 'spread': '17.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sitting Diastolic Blood Pressure', 'classes': [{'categories': [{'measurements': [{'value': '74.5', 'spread': '9.8', 'groupId': 'BG000'}, {'value': '75.9', 'spread': '9.2', 'groupId': 'BG001'}, {'value': '75.2', 'spread': '9.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-02-14', 'size': 1262278, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-03-13T15:11', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'dispFirstSubmitDate': '2024-01-25', 'completionDateStruct': {'date': '2023-01-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-06', 'studyFirstSubmitDate': '2017-01-05', 'resultsFirstSubmitDate': '2024-03-13', 'studyFirstSubmitQcDate': '2017-01-06', 'dispFirstPostDateStruct': {'date': '2024-06-07', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2024-06-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-06-06', 'studyFirstPostDateStruct': {'date': '2017-01-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Pulmonary Artery Pressure (mPAP) During Submaximal Exercise as Compared Between Placebo and Nitrite', 'timeFrame': 'Baseline and 10 weeks', 'description': 'Mean Pulmonary Artery Pressure measurement at submaximal exercise as compared between Placebo and Oral Nitrite at 10 weeks.'}], 'secondaryOutcomes': [{'measure': 'Difference in 6-minute Walk Test', 'timeFrame': 'Baseline to 10 weeks', 'description': 'The 6-minute walk test measures the distance an individual is able to walk over 6 minutes on a hard, flat surface. The subject is allowed to self-pace and rest as needed.\n\nThe number of subjects with available 6-minute walk tests do not match the total number of subjects in the study due to: one subject fracturing a foot and several subjects missing visit timepoints due to health issues resulting in 6 minute walk test not being performed.'}, {'measure': 'Change in Right Heart Catheterization (RHC) Hemodynamics - Pulmonary Capillary Wedge Pressure', 'timeFrame': 'During Week 10 follow-up at rest and at exercise', 'description': 'Right heart catheterization hemodynamic measures will be aggregated to determine if overall hemodynamic on Pulmonary Capillary Wedge Pressure are improved over the course of treatment.'}, {'measure': 'Change in Severity of Heart Failure', 'timeFrame': 'Baseline to Week 10', 'description': 'Determined by N-terminal pro b-type natriuretic peptide (NT-proBNP) plasma levels.\n\nThe number of subjects with available NT-proBNP values do not match the total number in the study as several subjects missed visit timepoints due to health issues resulting in NT-proBNP not being obtained.'}, {'measure': 'Change in Right Heart Catheterization (RHC) Hemodynamics - Trans Pulmonary Gradient', 'timeFrame': 'During Week 10 follow-up at rest and at exercise', 'description': 'Right heart catheterization hemodynamic measures will be aggregated to determine if overall hemodynamic on Trans Pulmonary Gradient are improved over the course of treatment.'}, {'measure': 'Change in Right Heart Catheterization (RHC) Hemodynamics - Pulmonary Vascular Resistance', 'timeFrame': 'During Week 10 follow-up at rest and at exercise', 'description': 'Right heart catheterization hemodynamic measures will be aggregated to determine if overall hemodynamic on Pulmonary Vascular Resistance are improved over the course of treatment.'}, {'measure': 'Change in Right Heart Catheterization (RHC) Hemodynamics - Cardiac Output', 'timeFrame': 'During Week 10 follow-up at rest and at exercise', 'description': 'Right heart catheterization hemodynamic measures will be aggregated to determine if overall hemodynamic on Cardiac Output are improved over the course of treatment.'}, {'measure': 'Number of Participants With Different Severities of Heart Failure', 'timeFrame': '10 weeks', 'description': 'Determined by NYHA functional classification changes. Class I - No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc.\n\nClass II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity.\n\nClass III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100 m). Comfortable only at rest.\n\nClass IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.\n\nWhile the change in severity of heart failure is listed as an end point, since this is ordinal data we cannot provide a p-value. We present the NYHA data at screening, crossover and 10 weeks.'}, {'measure': 'Change in Endurance Exercise Time', 'timeFrame': '10 weeks', 'description': 'The endurance exercise time will be measured from the start of loaded pedaling to volitional exhaustion and the worklaod has returned to unloaded pedaling.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pulmonary Hypertension Secondary', 'Heart Failure']}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to determine the clinical efficacy of oral inorganic nitrite verses placebo and the therapeutic response with regards to exercise tolerance in patients with pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF).', 'detailedDescription': 'This is a single-center, 22-week double-blind, randomized placebo-controlled cross-over trial of oral nitrite on exercise capacity and hemodynamic measurements in subjects with PH-HFpEF.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAge 18 years and older\n\nPH-HFpEF confirmed diagnosis by RHC:\n\n* Mean Pulmonary Arterial Pressure (mPAP) ≥ 25 mmHg AND\n* Pulmonary capillary wedge pressure (PWCP) ≥ 15 mmHg AND\n* Transpulmonary Gradient (TPG) ≥ 12 mmHg\n\nExclusion Criteria:\n\n* Age less than 18 years;\n* SBP \\> 170 or \\< 110 mmHg\n* DBP \\>95 or \\< 60 mmHg\n* Hemoglobin A1C \\> 10\n* Positive urine pregnancy test or breastfeeding;\n* Ejection Fraction (EF) \\< 40%;\n* Dementia\n* End-stage malignancy\n* Major cardiovascular event or procedure within 6 weeks prior to enrollment\n* Severe valvular disease\n* Known chronic psychiatric or medical conditions that may increase the risk associated with study participation in the judgment of the investigator, would make the subject inappropriate for entry into this study;\n* Smoker\n* Hemoglobin \\<9 g/dL\n* Serum creatinine \\> 3.0 mg/dL\n* Receipt of an investigational product or device, or participation in a drug research study within a period of 15 days; RHC \\< 2 weeks from study screening RHC unless clinically indicated'}, 'identificationModule': {'nctId': 'NCT03015402', 'acronym': 'PH-HFpEF', 'briefTitle': 'Oral Nitrite in Patients With Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Phase II Clinical Investigation of Oral Nitrite in Patients With Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction (PH-HFpEF)', 'orgStudyIdInfo': {'id': 'STUDY20010014'}, 'secondaryIdInfos': [{'id': '5P01HL103455', 'link': 'https://reporter.nih.gov/quickSearch/5P01HL103455', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sodium Nitrite', 'description': 'Study', 'interventionNames': ['Drug: Sodium Nitrite']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Control', 'interventionNames': ['Drug: Placebo Oral Capsule']}], 'interventions': [{'name': 'Sodium Nitrite', 'type': 'DRUG', 'otherNames': ['study'], 'description': '40 mg PO (by mouth) TID (three times each day) for 10 weeks', 'armGroupLabels': ['Sodium Nitrite']}, {'name': 'Placebo Oral Capsule', 'type': 'DRUG', 'otherNames': ['control'], 'description': 'Placebo capsule that is of identical size, shape, and color to experimental drug capsule PO (by mouth) TID (three times each day) for 10 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Michael Risbano, MD, MA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Medicine', 'investigatorFullName': 'Michael Risbano', 'investigatorAffiliation': 'University of Pittsburgh'}}}}