(-)-Epicatechin and Pulmonary Arterial Hypertension

NCT01880866 | Withdrawn Phase 1

• 1 other identifier: EPI
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Arterial Hypertension

Keywords

PAH

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Endothelial function and hemodynamics

  up to 5 hours after right heart catheterization

Study Arms (1)

(-)-Epicatechin

EXPERIMENTAL

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

Drug: (-)-Epicatechin

Interventions

(-)-Epicatechin DRUG

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.

(-)-Epicatechin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female age 18 or older
• NYHA Class II-!V
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF

San Francisco, California, 94110, United States

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

Catechin

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chromans; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Flavonoids; Chromones; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Christopher Barnett, MD, MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2013
• First Posted: June 19, 2013
• Study Start: July 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: September 10, 2014

Record last verified: 2014-09

Locations

US (1)