Acute Effects of Oral Ketone Ester on Cardiac Function in Patients With COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Left Ventricular ejection fraction
研究概览
简要总结
Based on Chinese studies, cardiac injury occurs in 20-30% of hospitalized patients and contributes to 40% of deaths. There are many possible mechanisms of cardiac injury in COVID-19 patients and increased myocardial oxygen demand and decreased myocardial oxygen supply are likely contributors to increased risk of myocardial infarction and heart failure. Interventions reducing the risk of cardiac injury are needed.
Ketone bodies, such as 3-hydroxybutyrate and acetoacetate, can maintain ATP production in the heart and brain during starvation. It has been suggested that ketone bodies are more efficient substrates of energy metabolism than glucose, with a lower oxygen consumption per ATP-molecule produced. In addition, the reduction in hospitalizations due to heart failure observed in type 2 diabetes patients treated with sodium-glucose cotransporter 2 inhibitors, is suggested to be partly attributable to increased levels of 3-hydroxybutyrate. Infusion with 3-hydroxybutyrate reaching a plasma level of approximately 3 mM had acute beneficial hemodynamic effects in patients with heart failure and in healthy controls in a study by Nielsen et al. Improved haemodynamics and reduced systemic oxygen consumption might be of great benefit in patients with COVID-19.
The primary endpoint is left ventricular ejection fraction. Secondary endpoints are conventional echocardiography parameters, peripheral blood oxygen saturation, venous blood oxygen saturation and urine creatinine clearance.
The study population are twelve previously hospitalized patients with COVID-19
The study design is a randomized placebo-controlled double-blinded crossed-over acute intervention study.
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
- •Patients previously hospitalized at hospitals of greater Copenhagen and the Zealand region with a laboratory confirmed diagnosis of COVID-19 > 18 years of age.
排除标准
- •Persons not able to cooperate
- •Persons unable to understand and sign "informed consent"
- •Diagnosis with chronic obstructive pulmonary disease
- •Diagnosis with asthma
- •Active treatment with sodium-glucose transporter 2 inhibitors
- •eGFR < 15 ml/min/1.73m2
- •insulin-dependent diabetes
结局指标
主要结局
Left Ventricular ejection fraction
时间窗: 1 hour
Echocardiography
次要结局
- Peripheral blood oxygen saturation(5 minutes)
- Venous blood oxygen saturation(5 minutes)
- Cardiac output(1 hour)
- Global longitudinal strain(1 hour)
- Urine creatinine clearance(12 hours)