Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1
INTERVENTIONAL
2013-07-31
2014-01-31
Brief Summary
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(-)-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.
Our 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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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(-)-Epicatechin
A single dose of 100mg or 200mg (-)-Epicatechin to be administered orally
(-)-Epicatechin
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.
Interventions
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(-)-Epicatechin
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.
Eligibility Criteria
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Inclusion Criteria
* NYHA Class II-!V
* 6 minute walk distance \< 450 meters
* Outpatients with suspected WHO group I PAH or and established diagnosis of WHO group I PAH undergoing clinically indicated right heart catheterization
* Written informed consent obtained from subject and ability for subject to comply with the requirements of study
Exclusion Criteria
* Breast feeding
* Systolic blood pressure \<100 or \>160
* History of migraine headaches
* Allergy or intolerance to chocolate, tea or wine
* Subject is considered unsuitable for the study in the opinion of the investigator, nurse practitioner, or study physician for any other reason
18 Years
ALL
No
Sponsors
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University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Christopher Barnett, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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UCSF
San Francisco, California, United States
Countries
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Other Identifiers
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EPI
Identifier Type: -
Identifier Source: org_study_id
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