An Open Label Pilot Study of Purified (-)-Epicatechin to Improve Hemodynamics in Pulmonary Arterial Hypertension

University of California, San Francisco1 site in 1 countryJuly 2013

ConditionsPulmonary Arterial Hypertension

Interventions(-)-Epicatechin

Drugs(-)-Epicatechin

Overview

Phase: Phase 1
Intervention: (-)-Epicatechin
Conditions: Pulmonary Arterial Hypertension
Sponsor: University of California, San Francisco
Locations: 1
Primary Endpoint: Pulmonary Vascular Resistance Index
Status: Withdrawn
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

July 2013

End Date

January 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University of California, San Francisco

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female age 18 or older
•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

•Pregnancy
•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

Arms & Interventions

(-)-Epicatechin

A single dose of 100mg or 200mg (-)-Epicatechin to be administered orally

Intervention: (-)-Epicatechin

Outcomes

Primary Outcomes

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.