An Open Label Pilot Study of Purified (-)-Epicatechin to Improve Hemodynamics in Pulmonary Arterial Hypertension
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Pulmonary Vascular Resistance Index
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
(-)-Epicatechin
A single dose of 100mg or 200mg (-)-Epicatechin to be administered orally
干预措施: (-)-Epicatechin (Drug)
结局指标
主要结局
Pulmonary Vascular Resistance Index
时间窗: 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.
次要结局
- Endothelial function and hemodynamics(up to 5 hours after right heart catheterization)