(-)-Epicatechin and Pulmonary Arterial Hypertension
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|ClinicalTrials.gov Identifier: NCT01880866|
Recruitment Status : Withdrawn
First Posted : June 19, 2013
Last Update Posted : September 10, 2014
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.
(-)-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.
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Arterial Hypertension||Drug: (-)-Epicatechin||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label Pilot Study of Purified (-)-Epicatechin to Improve Hemodynamics in Pulmonary Arterial Hypertension|
|Study Start Date :||July 2013|
|Estimated Primary Completion Date :||January 2014|
|Estimated Study Completion Date :||January 2014|
A single dose of 100mg or 200mg (-)-Epicatechin to be administered orally
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.
- Pulmonary Vascular Resistance Index [ Time Frame: up to 5 hours after right heart catheterization ]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.
- Endothelial function and hemodynamics [ Time Frame: up to 5 hours after right heart catheterization ]Secondary objectives are to determine if endothelial function, right heart function, nitric oxide and mitochondrial function improve following consumption of purified (-)-epicatechin.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01880866
|United States, California|
|San Francisco, California, United States, 94110|
|Principal Investigator:||Christopher Barnett, MD, MPH||University of California, San Francisco|