(-)-Epicatechin and Pulmonary Arterial Hypertension
An Open Label Pilot Study of Purified (-)-Epicatechin to Improve Hemodynamics in Pulmonary Arterial Hypertension
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.
研究概览
研究类型
阶段
- 阶段1
联系人和位置
学习地点
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California
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San Francisco、California、美国、94110
- UCSF
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:(-)-Epicatechin
A single dose of 100mg or 200mg (-)-Epicatechin to be administered orally
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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.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Pulmonary Vascular Resistance Index
大体时间: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.
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up to 5 hours after right heart catheterization
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Endothelial function and hemodynamics
大体时间: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.
|
up to 5 hours after right heart catheterization
|
合作者和调查者
调查人员
- 首席研究员:Christopher Barnett, MD, MPH、University of California, San Francisco
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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