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(-)-Epicatechin and Pulmonary Arterial Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01880866
Recruitment Status : Withdrawn
First Posted : June 19, 2013
Last Update Posted : September 10, 2014
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Drug: (-)-Epicatechin Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Pilot Study of Purified (-)-Epicatechin to Improve Hemodynamics in Pulmonary Arterial Hypertension
Study Start Date : July 2013
Estimated Primary Completion Date : January 2014
Estimated Study Completion Date : January 2014


Arm Intervention/treatment
Experimental: (-)-Epicatechin
A single dose of 100mg or 200mg (-)-Epicatechin to be administered orally
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Endothelial function and hemodynamics [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01880866


Locations
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United States, California
UCSF
San Francisco, California, United States, 94110
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Christopher Barnett, MD, MPH University of California, San Francisco

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01880866    
Other Study ID Numbers: EPI
First Posted: June 19, 2013    Key Record Dates
Last Update Posted: September 10, 2014
Last Verified: September 2014
Keywords provided by University of California, San Francisco:
PAH
Additional relevant MeSH terms:
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Familial Primary Pulmonary Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases