Treatment With the Ketone Body 3-hydroxybutyrate in Patients With Acute Heart Failure

  • STATUS
    Recruiting
  • End date
    May 1, 2022
  • participants needed
    12
  • sponsor
    University of Aarhus
Updated on 19 July 2021
diuretics
loop diuretic
3-hydroxybutyrate
maltodextrin

Summary

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.

Details
Condition Acute Heart Failure
Treatment Maltodextrin, HVMN Ketone Ester
Clinical Study IdentifierNCT04442555
SponsorUniversity of Aarhus
Last Modified on19 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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