Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-02-23 @ 6:28 AM
Study NCT ID:
NCT02057458
Status:
COMPLETED
Last Update Posted:
2020-04-24
First Post:
2014-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Blood Flow and Vascular Function in Cystic Fibrosis
Sponsor:
Organization:
Raw JSON
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[{'categories': [{'measurements': [{'value': '160', 'spread': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '54', 'spread': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body mass index', 'classes': [{'categories': [{'measurements': [{'value': '20.4', 'spread': '4.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body fat', 'classes': [{'categories': [{'measurements': [{'value': '28.5', 'spread': '7.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '%', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'O2 saturation', 'classes': [{'categories': [{'measurements': [{'value': '98', 'spread': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '%', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Systolic blood pressure', 'classes': [{'categories': [{'measurements': [{'value': '108', 'spread': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Diastolic blood pressure', 'classes': [{'categories': [{'measurements': [{'value': '65', 'spread': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2014-01-27', 'size': 546179, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-04-03T12:15', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': 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'timeFrame': 'pre-treatment Baseline and 1 hour post-treatment', 'description': 'FMD determined one hour after ingestion of 50 mg Sildenafil or placebo'}, {'measure': 'Baseline Diameter', 'timeFrame': 'pre-treatment Baseline and following 4 weeks sub-chronic treatment', 'description': 'Brachial Artery Diameter during FMD (pre-occlusion or "baseline")'}, {'measure': 'Peak Diameter', 'timeFrame': 'pre-treatment Baseline and following 4 weeks sub-chronic treatment', 'description': 'Peak Brachial Artery Diameter during FMD (post-occlusion)'}, {'measure': 'Absolute Change in Diameter', 'timeFrame': 'pre-treatment Baseline and following 4 weeks sub-chronic treatment', 'description': 'Absolute change in brachial artery diameter taken from the FMD assessment'}, {'measure': 'FEV1 (% Predicted)', 'timeFrame': 'pre-treatment Baseline, 1 hour post-treatment, and following 4 weeks sub-chronic treatment', 'description': 'Forced Expiratory Volume in the first second expressed as a percent predicted.'}, {'measure': 'VO2 Peak (Absolute)', 'timeFrame': 'pre-treatment Baseline, 1 hour post-treatment, and following 4 weeks sub-chronic treatment', 'description': 'absolute (L/min) peak oxygen consumption during maximal exercise test'}, {'measure': 'VO2 Peak (Relative)', 'timeFrame': 'pre-treatment Baseline, 1 hour post-treatment, and following 4 weeks sub-chronic treatment', 'description': 'relative (mL/kg/min) peak oxygen consumption during maximal exercise test'}, {'measure': 'VO2 Peak (Percent Predicted)', 'timeFrame': 'pre-treatment Baseline and 1 hour post-treatment, and 4 weeks sub-chronic treatment', 'description': 'Maximal Oxygen consumption expressed as percent predicted taken from maximal exercise test.'}, {'measure': 'VE Peak', 'timeFrame': 'pre-treatment Baseline, 1 hour post-treatment, and following 4 weeks sub-chronic treatment', 'description': 'peak ventilation (L/min) during maximal exercise test'}, {'measure': 'RER Peak', 'timeFrame': 'pre-treatment Baseline, 1 hour post-treatment, and following 4 weeks sub-chronic treatment', 'description': 'peak respiratory exchange ratio during maximal exercise test'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['arterial stiffness', 'flow-mediated dilation', 'endothelial function', 'pulse wave velocity', 'inflammation', 'oxidative stress', 'pulmonary function test', 'Cystic Fibrosis', 'Lung Disease', 'Nitric Oxide', 'Exercise Capacity', 'CF', 'Muscle Function', 'Sildenafil', 'Viagra', 'Revatio'], 'conditions': ['Cystic Fibrosis']}, 'referencesModule': {'references': [{'pmid': '33105385', 'type': 'DERIVED', 'citation': 'Rodriguez-Miguelez P, Seigler N, Ishii H, Crandall R, McKie KT, Forseen C, Harris RA. Exercise Intolerance in Cystic Fibrosis: Importance of Skeletal Muscle. Med Sci Sports Exerc. 2021 Apr 1;53(4):684-693. doi: 10.1249/MSS.0000000000002521.'}], 'seeAlsoLinks': [{'url': 'http://www.livep.net', 'label': 'Laboratory of Integrative Vascular and Exercise Physiology'}]}, 'descriptionModule': {'briefSummary': 'Cystic fibrosis (CF) has many health consequences. A reduction in the ability to perform exercise in patients with CF is related to greater death rates, steeper decline in lung function, and more frequent lung infections. However, the physiological mechanisms for this reduced exercise capacity are unknown. The investigators laboratory recently published the first evidence of systemic vascular dysfunction in patients with CF. Therefore, it is reasonable to suspect that the blood vessels are involved with exercise intolerance in CF. This study will look at how 1) blood flow and 2) artery function contribute to exercise capacity in CF.', 'detailedDescription': 'The most disturbing aspect of Cystic Fibrosis (CF) is the associated premature death. Low exercise capacity predicts death in patients with CF and is also associated with a steeper decline in lung function and more lung infections. A critical barrier to improving exercise tolerance in patients with CF is the investigators lack of knowledge regarding the different physiological mechanisms which contribute to their lower exercise capacity. We have compelling data to indicate that the blood vessels may contribute to the low exercise capacity in CF. The impact of this proof of concept investigation will test Phosphodiesterase Type 5 inhibitors (PDE5) inhibitors as a potential therapy in CF and will explore blood flow and endothelial function as potential mechanisms which contribute to exercise intolerance in CF. Improvements in exercise capacity will not only contribute to a better quality of live for patients with CF, it will also increase longevity in these patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria.\n\n* Diagnosis of CF and healthy controls\n* Men and women (greater than 18 yrs. old)\n* Resting oxygen saturation (room air) greater than 90%\n* Forced expiratory volume (FEV1) percent predicted greater than 30%\n* Patients with or without CF related diabetes\n* Traditional CF-treatment medications\n* Ability to perform reliable/reproducible pulmonary function tests (PFT)\n* Clinically stable for 2 weeks (no exacerbations or need for antibiotic treatment within 2 weeks of testing or major change in medical status)\n\nExclusion Criteria.\n\n* Children less than 17 years old\n* Body mass less than 20 kg\n* A diagnosis of pulmonary arterial hypertension (PAH)\n* FEV1 less than 30% of predicted\n* Resting oxygen saturation (SpO2) less than 90%\n* Self-reported to be a smoker\n* Current use of any vaso-active medications\n* History of migraine headaches\n* Pregnant or nursing at the time of the investigation\n* A clinical diagnosis of cardiovascular disease, hypertension, or CF related diabetes'}, 'identificationModule': {'nctId': 'NCT02057458', 'acronym': 'CF-FLOW', 'briefTitle': 'Blood Flow and Vascular Function in Cystic Fibrosis', 'organization': {'class': 'OTHER', 'fullName': 'Augusta University'}, 'officialTitle': 'Role of Blood Flow and Vascular Function on Exercise Capacity in Cystic Fibrosis', 'orgStudyIdInfo': {'id': 'DK100783'}, 'secondaryIdInfos': [{'id': 'R21DK100783', 'link': 'https://reporter.nih.gov/quickSearch/R21DK100783', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acute Study: Sildenafil first, then Placebo', 'description': 'In randomized order, on two separate days, endothelial function and exercise capacity will be determined 1 hour following a single dose of sildenafil (50 mg) or placebo.', 'interventionNames': ['Drug: Sildenafil (Acute-1 hour)', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Acute Study: Placebo first, then Sildenafil', 'description': 'In randomized order, on two separate days, endothelial function and exercise capacity will be determined 1 hour following a single dose of sildenafil (50 mg) or placebo.', 'interventionNames': ['Drug: Sildenafil (Acute-1 hour)', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Sub-Chronic Study Sildenafil', 'description': 'Following the acute study, patients will be instructed to take 20 mg of sildenafil, three times a day, for 4 weeks. Endothelial function will be determined within 48 hours following the last dose.', 'interventionNames': ['Drug: Sildenafil (Subchronic-4 weeks)']}], 'interventions': [{'name': 'Sildenafil (Acute-1 hour)', 'type': 'DRUG', 'otherNames': ['Viagra', 'Revatio'], 'description': 'Vascular function will be assessed 1 hour following oral ingestion of sildenafil (50 mg)', 'armGroupLabels': ['Acute Study: Placebo first, then Sildenafil', 'Acute Study: Sildenafil first, then Placebo']}, {'name': 'Sildenafil (Subchronic-4 weeks)', 'type': 'DRUG', 'otherNames': ['Viagra', 'Revatio'], 'description': 'Vascular function will be assessed 4 weeks following 20 mg three times per day (TID) of sildenafil for four weeks', 'armGroupLabels': ['Sub-Chronic Study Sildenafil']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Sugar pill designed to mimic the sildenafil treatment', 'armGroupLabels': ['Acute Study: Placebo first, then Sildenafil', 'Acute Study: Sildenafil first, then Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30912', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Augusta University', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}], 'overallOfficials': [{'name': 'Ryan Harris, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Augusta University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Augusta University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Ryan Harris', 'investigatorAffiliation': 'Augusta University'}}}}