Effects of Epicatechin on Functional Capacity, Skeletal Muscle Structure and Diastolic Function in Patients With Heart Failure With Preserved Ejection Fraction (HFPEF)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Change from baseline in pre-specified biomarker levels in blood, skeletal muscle, and urine
研究概览
简要总结
The major goal of this proposal is to characterize the ability of epicatechin which a component of dark chocolate to improve the
- structural and functional features of skeletal muscle (SkM)
- exercise capacity (as assessed by VO2 max)
- parameters of diastolic heart function (as assessed by echocardiography)
We propose that a 3 month treatment with epicatechin (through CocoaVia® capsules) will lead to a significant improvement in exercise capacity and diastolic function.
详细描述
Patient Inclusion/Exclusion Criteria:
- New York Heart Association Class II/III HF with preserved ejection fraction (EF) of >50%.
- Nonsmokers
- Subject not taking Coumadin, Xarelto, Prasugrel or Pradaxa. Patients on Plavix for drug eluting stent will not be excluded.
- Ages between 40-65. We will exclude any women of child bearing potential
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Medically Diagnosed Heart Failure with Ejection Fraction of >55%
- •BMI 27-32
- •No Significant HbA1C fluctuations in past 6 months
排除标准
- •Smoking or quit smoking less than 1 year prior to enrollment
- •Substance Abuse
- •Taking Coudmadin or Pradaxa
结局指标
主要结局
Change from baseline in pre-specified biomarker levels in blood, skeletal muscle, and urine
时间窗: Baseline and 3 months
Skeletal muscle biopsies and blood draws will be performed to obtain experimental samples
Change from baseline in exercise capacity
时间窗: Baseline and 3 months
Objectively evaluate exercise capacity through cycle ergometry to measure VO2 max
Change from baseline in skeletal muscle metabolism
时间窗: Baseline and 3 months
The change in skeletal muscle metabolism will be evaluated by magnetic resonance spectroscopy
次要结局
未报告次要终点
研究者
Pam Taub, MD
Dr. Pam Taub
University of California, San Diego