(-)-Epicatechin and Pulmonary Arterial Hypertension

Phase 1

Withdrawn

• Conditions: Pulmonary Arterial Hypertension
• Interventions: Drug: (-)-Epicatechin

• Registration Number: NCT01880866
• Lead Sponsor: University of California, San Francisco

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-05-28
• Study First Submitted QC: 2013-06-14
• Study First Posted: 2013-06-19
• Study Start: 2013-07
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-09
• Last Update Posted: 2014-09-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Pulmonary Vascular Resistance Index	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.

Secondary Outcome Measures

Name	Time	Method
Endothelial function and hemodynamics	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.

Trial Locations

Locations (1)

UCSF; 🇺🇸 San Francisco, California, United States