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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01880866 |
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Date of registration:
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28/05/2013 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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(-)-Epicatechin and Pulmonary Arterial Hypertension
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Scientific title:
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An Open Label Pilot Study of Purified (-)-Epicatechin to Improve Hemodynamics in Pulmonary Arterial Hypertension |
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Date of first enrolment:
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July 2013 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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http://clinicaltrials.gov/show/NCT01880866 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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United States
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Contacts
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Name:
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Christopher Barnett, MD, MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of California, San Francisco |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Pulmonary Arterial Hypertension
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Intervention(s)
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Drug: (-)-Epicatechin
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Primary Outcome(s)
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Pulmonary Vascular Resistance Index
[Time Frame: up to 5 hours after right heart catheterization]
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Secondary Outcome(s)
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Endothelial function and hemodynamics
[Time Frame: up to 5 hours after right heart catheterization]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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