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临床试验/NCT04698005
NCT04698005Unknown3 期

Exogenous Ketones for Acutely Decompensated Heart Failure

Institute for Clinical and Experimental Medicine2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2020年12月2日最近更新:
适应症

试验速览

阶段
3 期
发起方
入组人数
24
试验地点
2
主要终点
Maximum change of stroke volume index

研究概览

简要总结

This study will evaluate whether supplementation of exogenous ketones in patients with severe left ventricular dysfunction and acutely decompensated heart failure requiring inotropic therapy would improve the patient's hemodynamics and symptoms.

详细描述

The study will include patients with acutely decompensated chronic heart failure requiring inotropic therapy for the syndrome of low cardiac output. While being on the inotropic therapy, the patients will be randomized to oral supplementation of exogenous ketones vs. placebo, which will be repeatedly administered over 9 hours. The patients will undergo continuous invasive hemodynamic monitoring by pulmonary artery catheter, repeated laboratory assessment, and repeated assessment of the severity of symptoms for 24 hours.

Exogenous ketones will be administered orally using monoester 3-OHB concentrate without added salts (25g 3-OHB in 65ml H.V.M.N Ketone Ester, H.V.M.N, USA or equivalent). The drink will be administered over 10 mins every 3 hours, 3 times in a row (hour 0, 3, 6).

All patients with K<3.7 mmol/l will receive a continuous infusion of 7.5% potassium until reach target K levels of 4.0-4.9 mmol /l. Glycemia will be controlled as needed by insulin and dextrose to maintain glucose concentration of 4 - 12 mmol/l

All patients will receive standard treatment of acute heart failure, including intravenous diuretics and inotropic therapy. The recommended inotropic therapy will include milrinone 0.5 ug/kg/min, levosimendan 0.1 ug/kg/min up to 25mg without initial bolus, or dobutamine 0.5 ug/kg/min in patients without chronic therapy with beta-blockers.

The severity of symptoms will be self-reported by the patient using 1-10 visual analog scale.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

盲法说明

The participant and the physician in charge of the participant will be blinded to the given treatment (ketone drink vs. placebo)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Chronic heart failure due ischemic or nonischemic cardiomyopathy
  • Acute decompensation of heart failure with the need of inotropes
  • Achievement of relative stabilization on inotropes (INTERMACS class >2)
  • Left ventricular ejection fraction <= 35%
  • Age >18 years

排除标准

  • Deteriorating cardiogenic shock with likely need of mechanical circulatory support in the subsequent 48 hours
  • Chronic kidney disease grade 4 or 5
  • Diabetic ketoacidosis (3-OHB >2mmol/l at baseline)
  • Hemodynamic severe arrhythmias
  • Acute heart failure due to transient triggers (acute coronary syndrome, atrial fibrillation, infection etc..)
  • Contraindications to invasive hemodynamic monitoring

结局指标

主要结局

Maximum change of stroke volume index

时间窗: Maximum value of stroke volume index measured between hour 1 - 3 of the study protocol at 15-minute intervals

Maximum change of stroke volume index (ml/m2) between baseline and hour 1 - 3

Maximum change of cardiac index

时间窗: Maximum value of cardiac index measured between hour 1 - 3 of the study protocol at 15-minute intervals

Maximum change of cardiac index (L/m2) between baseline and hour 1 - 3

Change of mean cardiac index

时间窗: Mean value of cardiac index measured every 15 minutes during 9 hours of the study protocol

Difference between baseline cardiac index (L/m2) and mean cardiac index during the study protocol

Change of mean stroke volume index

时间窗: Mean value of stroke volume index measured every 15 minutes during 9 hours of the study protocol

Difference between baseline stroke volume index and mean stroke volume index (ml/m2) during the study protocol

次要结局

  • Change in patient/symptoms(Symptoms scored at hours 0, 1, 10, 24 and expressed as an area under the curve)

研究者

发起方
Institute for Clinical and Experimental Medicine
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Marek Sramko

Head of the Department of Acute Cardiology

Institute for Clinical and Experimental Medicine

研究点 (2)

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