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(-)-Epicatechin and Pulmonary Arterial Hypertension

NCT01880866 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2014-09-10

No results posted yet for this study

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.

Conditions

Interventions

DRUG

(-)-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.

Sponsors & Collaborators

Principal Investigators

  • Christopher Barnett, MD, MPH · University of California, San Francisco

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2014-01-31
Completion
2014-01-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01880866 on ClinicalTrials.gov