跳至主要内容
临床试验/NCT04379934
NCT04379934Unknown不适用

Functional and Metabolic Effects of Ketone Bodies on Human Atrial Tissue in Patients With and Without Heart Failure

University of Aarhus2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年6月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
2
主要终点
Contractile force recovery

研究概览

简要总结

This proof of concept study aims to evaluate the effects of applying ketone bodies to human atrial tissue biopsies using an atrial strips model and high resolution respirometry.

详细描述

Ketone bodies are high energy molecules which are naturally occurring in the body during fasting or stress.

Recently, ketone bodies have been shown to improve cardiac function in patients with heart failure(1) through a mechanism, which has yet to be elaborated.

We wish to evaluate the effects of ketone body administration on cardiac tissue subjected to ischemia reperfusion injury. We will evaluate contractile force of the and the mitochondrial performance. Cardiac atrial tissue will be obtained from patients undergoing coronary artery bypass grafting (CABG) or valve replacement surgery. Patients will be recruited after signing an informed consent and allocated in heart failure / non-heart failure groups based on a clinical evaluation.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • EF < / > 45%, hospitalized for elective CABG or heart valve surgery

排除标准

  • Myocardial infarction within 4 weeks, atrial fibrillation, medically treated thyroid disease, oral treatment with opioids.

结局指标

主要结局

Contractile force recovery

时间窗: Outcome will be assessed within a year when the inclusion of patients is complete

Atrial strips model, contractile force (nm\*mm\^-1) during stabilization, ischemia and reperfusion

次要结局

  • Mitochondrial respiratory capacity(Outcome will be assessed within a year when the inclusion of patients is complete)
  • Mitochondrial Reactive Oxygen Species production(Outcome will be assessed within a year when the inclusion of patients is complete)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

Functional and Metabolic Effects of Ketone Bodies on... | 临床试验