Treatment With the Ketone Body 3-hydroxybutyrate in Patients With Acute Heart Failure
试验速览
- 阶段
- 1 期
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Cardiac Output (L/min)
研究概览
简要总结
Background:
Acute heart failure is a potentially life-threatening condition, reaching mortality rates of up to 50% in advanced cases. The investigators have shown that infusion of ketone bodies increase cardiac output by 40% in stabile patients with chronic heart failure. However, there are no data showing the effects of ketone on patients with acute heart failure
Objectives:
To investigate the effect of ketone supplementation in patients with acute heart failure and cardiogenic shock, using two different types of oral ketone supplements.
Methods:
The investigators will conduct four randomized placebo-controlled studies, to investigate the hemodynamic effect of exogenous ketones in acute heart failure and cardiogenic shock.
Perspectives:
The present study will determine the potential beneficial effects of ketone supplements in patients with acute 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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Hospitalized with worsening HF or de novo diagnosis of HF
- •LVEF < 50%
- •Treatment with intravenous loop diuretics during the hospitalization and/or increased dosage of oral diuretics.
排除标准
- •Cardiogenic shock
- •Systolic Blood Pressure <85 mmHg
- •Acute myocardial infarction other than type II <5 days prior to randomization *
- •Severe uncorrected cardiac valve disease
- •Expected or possible need for hemodialysis as judged by the investigator
- •Ongoing inotropic treatment
- •Possible need for advanced heart failure treatment (LVAD, heart transplantation) as judged by the investigator.
- •Ongoing, severe infection
- •Severe respiratory distress (SAT<90% or RF> 24/min or receiving more than 2 l O2/min or intubated)
- •Atrial Fibrillation with heart >120 beats per minute
- •Inability to cooperate to or accept oral intake of food, including presence of major gastrointestinal discomfort.
- •If suspected or confirmed acute myocardial infarction as cause of acute heart failure, patients can be recruited 5 days after hospitalization in the absence of malignant arrhythmias (e.g. ventricular tachycardia) or clinically significant residual angina pectoris.
结局指标
主要结局
Cardiac Output (L/min)
时间窗: 3 hours - Area under the curve
Right Heart Catherization
Left Ventricular Ejection Fraction
时间窗: 3 hours - Area under the curve
Echocardiography
次要结局
- Left Ventricular Outflow Tract Velocity Time Integral (cm)(3 hours - Area under the curve)
- Left Ventricular Filling Pressure (mmHg)(3 hours - Area under the curve)
研究者
Kristian Hylleberg Christensen
MD, Principal Investigator
University of Aarhus