Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2026-01-04 @ 4:27 AM
Study NCT ID:
NCT01880866
Status:
WITHDRAWN
Last Update Posted:
2014-09-10
First Post:
2013-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
(-)-Epicatechin and Pulmonary Arterial Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000081029', 'term': 'Pulmonary Arterial Hypertension'}], 'ancestors': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002392', 'term': 'Catechin'}], 'ancestors': [{'id': 'D002839', 'term': 'Chromans'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005419', 'term': 'Flavonoids'}, {'id': 'D002867', 'term': 'Chromones'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2014-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-09-09', 'studyFirstSubmitDate': '2013-05-28', 'studyFirstSubmitQcDate': '2013-06-14', 'lastUpdatePostDateStruct': {'date': '2014-09-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pulmonary Vascular Resistance Index', 'timeFrame': 'up to 5 hours after right heart catheterization', 'description': 'This study will assess acute hemodynamic effects, specifically effects on pulmonary vascular resistance index (PVRI), of a single dose of purified (-)-epicatechin in patients with patients with PAH.'}], 'secondaryOutcomes': [{'measure': 'Endothelial function and hemodynamics', 'timeFrame': 'up to 5 hours after right heart catheterization', 'description': 'Secondary objectives are to determine if endothelial function, right heart function, nitric oxide and mitochondrial function improve following consumption of purified (-)-epicatechin.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['PAH'], 'conditions': ['Pulmonary Arterial Hypertension']}, 'descriptionModule': {'briefSummary': 'Pulmonary arterial hypertension (PAH) is a progressive disease that results in severe activity limitation and death. There are few treatments for PAH and the available medications are expensive, difficult to administer and have significant toxicities.\n\n(-)-Epicatechin is a non-toxic compound that naturally occurs in foods such as tea, wine and chocolate. Clinical intervention studies using dark chocolate in normal volunteers and subjects at risk for or with established cardiovascular disease have demonstrated improvements in peripheral and coronary vascular endothelial function, blood pressure, lipids, glucose tolerance and inflammatory markers.\n\nOur study intends to examine the hemodynamics effects of purified (-)-epicatechin in subjects with pulmonary arterial hypertension. We hypothesize purified (-)-epicatechin will reduce pulmonary vascular resistance in patients with pulmonary arterial hypertension.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female age 18 or older\n* NYHA Class II-!V\n* 6 minute walk distance \\< 450 meters\n* Outpatients with suspected WHO group I PAH or and established diagnosis of WHO group I PAH undergoing clinically indicated right heart catheterization\n* Written informed consent obtained from subject and ability for subject to comply with the requirements of study\n\nExclusion Criteria:\n\n* Pregnancy\n* Breast feeding\n* Systolic blood pressure \\<100 or \\>160\n* History of migraine headaches\n* Allergy or intolerance to chocolate, tea or wine\n* Subject is considered unsuitable for the study in the opinion of the investigator, nurse practitioner, or study physician for any other reason'}, 'identificationModule': {'nctId': 'NCT01880866', 'briefTitle': '(-)-Epicatechin and Pulmonary Arterial Hypertension', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'An Open Label Pilot Study of Purified (-)-Epicatechin to Improve Hemodynamics in Pulmonary Arterial Hypertension', 'orgStudyIdInfo': {'id': 'EPI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '(-)-Epicatechin', 'description': 'A single dose of 100mg or 200mg (-)-Epicatechin to be administered orally', 'interventionNames': ['Drug: (-)-Epicatechin']}], 'interventions': [{'name': '(-)-Epicatechin', 'type': 'DRUG', 'description': 'A single dose of purified (-)-epicatechin will be administered orally to subjects after a regularly scheduled right heart catheterization. The subjects will be monitored for 5 hours and released.', 'armGroupLabels': ['(-)-Epicatechin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94110', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Christopher Barnett, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}