Physiological Effects of Dietary Supplement Ketone Ester on the Heart
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in Left Ventricular Ejection Fraction
研究概览
简要总结
The study is aimed to phenotype with cardiac MRI the physiological effects of ketone esters on the heart. Patients with heart failure will be recruited and given ketone esters or placebo in a randomized fashion. Cardiac MRI will be performed at baseline and after 12weeks follow up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
Both participant and investigators will be blinded. A representative in the center will be in charge of maintaining encrypted key.
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
- •heart failure EF < 40%
排除标准
- •Claustrophobia
- •Contraindicated implanted device
研究组 & 干预措施
Placebo
Placebo given that mimics taste, weight, and size of the interventional supplement mirroring the same time points as the ketone ester supplement group. Mirrored imaging with MRI as well.
干预措施: Placebo (Dietary Supplement)
Ketone ester supplement
Ketone ester given daily for 12 weeks and scanned before and after intervention with MRI.
干预措施: Ketone Ester (Dietary Supplement)
结局指标
主要结局
Change in Left Ventricular Ejection Fraction
时间窗: Pre-intervention and up to 12 weeks after intervention
Measured with cardiac MRI the left ventricular ejection fraction at two points and then delta is calculated
次要结局
- Change in Creatine concentration(Pre-intervention and up to 12 weeks after intervention)
研究者
Christopher Nguyen
Director
The Cleveland Clinic