(-)-Epicatechin and Pulmonary Arterial Hypertension

Pulmonary Arterial Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01880866
• Other study ID #: EPI
• Status: Withdrawn
• Phase: Phase 1
• First received: May 28, 2013
• Last updated: September 9, 2014
• Start date: July 2013
• Est. completion date: January 2014

Study information

• Verified date: September 2014
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Pulmonary Arterial Hypertension

Intervention

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.

Locations

Country	Name	City	State
United States	UCSF	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary Vascular Resistance Index	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.	up to 5 hours after right heart catheterization	No
Secondary	Endothelial function and hemodynamics	Secondary objectives are to determine if endothelial function, right heart function, nitric oxide and mitochondrial function improve following consumption of purified (-)-epicatechin.	up to 5 hours after right heart catheterization	No