Weight-Adjusted Dosing of 3-OHB in Patients With Chronic Heart Failure
试验速览
- 阶段
- 2 期
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Cardiac Output (L/min)
研究概览
简要总结
We aim to investigate the hemodynamic effects of weight-adjusted dosing of ketone monoester en patients with chronic heart failure.
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
- Double (Participant, Outcomes Assessor)
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 HF: NYHA class II-III, left ventricular ejection fraction (LVEF) <40%
排除标准
- •Diabetes or HbA1c >48 mmol/mol, significant cardiac valve disease, severe stable angina pectoris, severe comorbidity as judged by the investigator, inability to give informed consent
研究组 & 干预措施
Ketone Monoester
Weight-adjusted dose of 3-OHB Monoester (KetoneAID KE4, Virginia, US) 0.5 g/kg (max 50 g)
干预措施: KetoneAid KE4 Pro Monoester (Dietary Supplement)
Placebo Treatment
Maltodextrin-based placebo (Science In Sport, UK) in isocaloric dose to the experimental arm.
干预措施: Science in Sport Go Enegy (Dietary Supplement)
Ketone Monoester in presence of low-dose insulin clamp
Same as experimental arm, but in the presence of a low-dose insulin clamp to suppress free fatty acid metabolism
干预措施: KetoneAid KE4 Pro Monoester (Dietary Supplement)
结局指标
主要结局
Cardiac Output (L/min)
时间窗: 3 hours - Area under the curve
Change in Cardiac output measured by Swann-Ganz Catherization during study period,
次要结局
- Blood Ketones(3 hours)
- Blood pH(3 hours)
- Left Ventricular Ejection Fraction(3 hours - Area under the curve)
研究者
Kristian Hylleberg Christensen
MD
Aarhus University Hospital