Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2026-03-05 @ 6:57 PM
Study NCT ID:
NCT04090866
Status:
TERMINATED
Last Update Posted:
2020-07-27
First Post:
2019-09-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiac Metabolic Remodeling After Pulmonary Vasodilator Therapy in Pulmonary Arterial Hypertension: A Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000081029', 'term': 'Pulmonary Arterial Hypertension'}, {'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'PI and sponsor will re-open study at new institution, will not transfer data due to COVID-19 situation', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-11-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-07-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-23', 'studyFirstSubmitDate': '2019-09-12', 'studyFirstSubmitQcDate': '2019-09-13', 'lastUpdatePostDateStruct': {'date': '2020-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ability to augment glucose uptake ("substrate flexibility"), defined as change in rate of glucose uptake from rest to exercise', 'timeFrame': '6 months', 'description': 'Substrate flexibility is defined as the change in myocardial to blood pool glucose uptake rate from rest to exercise.'}], 'secondaryOutcomes': [{'measure': 'Change in substrate flexibility after initiation of pulmonary vasodilator therapy', 'timeFrame': '6 months', 'description': 'Substrate flexibility is defined as the change in myocardial to blood pool glucose uptake rate from rest to exercise. Substrate flexibility before and after pulmonary vasodilator therapy will be compared.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pulmonary arterial hypertension', 'right-sided heart failure', 'metabolism', 'PET/MRI'], 'conditions': ['Pulmonary Arterial Hypertension', 'Right-Sided Heart Failure']}, 'descriptionModule': {'briefSummary': 'Pulmonary arterial hypertension(PAH) is associated with the development of right heart failure. In the setting of heart failure, the heart shifts to increasing dependence on glucose metabolism. In this study, the investigators will perform cardiac positron emission tomography/magnetic resonance imaging (PET/MRI) scans to measure glucose metabolism in the heart before and after initiation of pulmonary vasodilator therapy for pulmonary arterial hypertension.', 'detailedDescription': 'Pulmonary arterial hypertension is associated with the development of right heart failure. In the setting of heart failure, the heart shifts to increasing dependence on glucose metabolism. In this study, the investigators will perform cardiac positron emission tomography/magnetic resonance imaging (PET/MRI) scans to measure glucose metabolism in the heart before and after initiation of pulmonary vasodilator therapy for pulmonary arterial hypertension. By utilizing a rest-exercise protocol and continuous PET imaging acquisition, we can capture real-time changes in glucose uptake in the heart in response to acute exercise. By coupling these measures of dynamic glucose utilization with MRI-based cardiac function, we will determine cardiac metabolic efficiency.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with IPAH or CTD-PAH', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* World Health Organization(WHO) group PAH secondary into idiopathic pulmonary arterial hypertension(IPAH) or connective tissue disease associated pulmonary arterial hypertension (CTDPAH)\n* New York Heart Association (NYHA) classification I - III heart failure\n* Vasodilator therapy naive\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Metabolic disorders such as uncontrolled diabetes (A1c \\> 8%) that may interfere with FDG uptake\n* Baseline 6-minute walk distance (6MWD) \\< 400 feet or NYHA class IV heart failure\n* Musculoskeletal abnormalities that would prevent exercise\n* Contraindications to MRI'}, 'identificationModule': {'nctId': 'NCT04090866', 'briefTitle': 'Cardiac Metabolic Remodeling After Pulmonary Vasodilator Therapy in Pulmonary Arterial Hypertension: A Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'Cardiac Metabolic Remodeling After Pulmonary Vasodilator Therapy in Pulmonary Arterial Hypertension: A Pilot Study', 'orgStudyIdInfo': {'id': '2019-0286'}, 'secondaryIdInfos': [{'id': 'A534285', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'SMPH/MEDICINE/MEDICINE*P', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'Protocol Version 8/2/2019', 'type': 'OTHER', 'domain': 'UW Madison'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'PET/MRI', 'type': 'OTHER', 'description': 'Positron Emission Tomograph/Magnetic Resonance Imaging - participants will undergo PET/MRI prior to initiation of pulmonary vasodilator therapy and again 4-6 months after initiation of therapy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin-Madison', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Kara Goss, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin, Madison'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'collaborators': [{'name': 'United Therapeutics', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}