NCT05236335已完成不适用
Modulation of Circulating Levels of the Ketone Body 3-hydroxybutyrate in Patients With Type 2 Diabetes and Heart Failure With Preserved Ejection Fraction: Cardiovascular Effects.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Cardiac Output (L/min)
研究概览
简要总结
Heart failure (HF) is among the most common causes of death in patients with type 2 diabetes (T2D). Ketones, 3-hydroxybutyrate (3-OHB), have shown to have beneficial hemodynamics effect in patients with hearth failure with reduced ejection fraction. However, this have never been investigated in patients with heart failure with preserved ejection fraction (HFpEF).
In this study we would like to investigate the effect of 14 days modulation of circulating ketone body levels on cardiac function and exercise capacity in patients with HFpEF and T2D.
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, 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
- •Type 2 diabetes
- •LVEF > 40 %
- •a clinical diagnosis of HFpEF and/or left ventricular hypertrophy (posterior wall thickness > 12 mm) and/or previous myocardial infarction
- •age ≥ 18 years old,
- •one of the following criteria (a-d) should be fulfilled:
- •Echocardiographic signs of diastolic dysfunction E/e' > 8
- •Septal e ́< 7 cm/s and/or lateral e ́ < 10 cm/s
- •Left atrium volume index ≥34 mL/m2 and/or left atrial diameter > 4 cm
- •NT-proBNP > 125 pg/ml.
排除标准
- •Insulin treatment, inability to give informed consent
研究组 & 干预措施
Ketone ester
Experimental
干预措施: Ketone ester (Dietary Supplement)
Placebo
Placebo Comparator
干预措施: Placebo drink (Dietary Supplement)
结局指标
主要结局
Cardiac Output (L/min)
时间窗: 14 days ketone ester treatment
Right heart catheterization
次要结局
- Exercise capacity (METs)(14 days ketone ester treatment)
- Pulmonal wedge capillary Pressure (PCWP)(14 days ketone ester treatment)
研究者
研究点 (1)
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