Modulation of Circulating Levels of the Ketone Body 3-hydroxybutyrate in Patients With Chronic Heart Failure: Metabolic Effects
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Differences in lipolysis rate
研究概览
简要总结
Heart Failure (HF) is a major public health issue because the disease affects 1-2% of the Western population and the lifetime risk of HF is 20%. Despite major improvements in the management and care of patients with HF, the 1-year mortality in patients with HF is 13% and >50% of HF patients are admitted during a 2.5 year period. Furthermore, patients with HF have markedly decreased physical capacity and quality of life. Thus, there is a need for new treatment modalities in this group of patients.
It is well established that patients with heart failure have metabolic disturbances, including disturbed glucose metabolism with increasing insulin resistance, increased lipolysis, and disturbances in skeletal muscle homeostasis.
Presently there are no data on the clinical metabolic effects of long-term oral ketone-supplementation in patients with chronic HF.
In this study we aim to investigate the effect of 14 days modulation of circulating ketone body levels on endogenous protein, glucose, and fatty acid metabolism in patients with HFrEF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Chronic heart failure with NYHA II-III
- •Left ventricular ejection fraction ≤40%
- •Negative urine-HCG for women with childbearing potential
排除标准
- •Known diabetes or HbA1c ≥48 mmol/mol
- •Significant cardiac valve disease
- •Severe stable angina pectoris
- •Age <18 years
结局指标
主要结局
Differences in lipolysis rate
时间窗: 14 days of dietary supplement
Measured as differences in palmitate flux
次要结局
- Changes in glucose kinetic(14 days of dietary supplement)
- Changes in protein metabolism(14 days of dietary supplement)
研究者
Kristoffer Berg-Hansen
MD, Principal Investigator
University of Aarhus