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

Last updated: July 14, 2022
Sponsor: University of Aarhus
Overall Status: Active - Recruiting

Phase

1

Condition

Heart Failure

Hyponatremia

Congestive Heart Failure

Treatment

N/A

Clinical Study ID

NCT04442555
KETO-AHF1 1-10-72-59-19
  • Ages > 18
  • Male

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Hospitalized with worsening HF or de novo diagnosis of HF
  • LVEF < 50%
  • Treatment with intravenous loop diuretics during the hospitalization and/or increaseddosage of oral diuretics.

Exclusion

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) asjudged by the investigator.
  • Ongoing, severe infection
  • Severe respiratory distress (SAT<90% or RF> 24/min or receiving more than 2 l O2/minor intubated)
  • Atrial Fibrillation with heart >120 beats per minute
  • Inability to cooperate to or accept oral intake of food, including presence of majorgastrointestinal discomfort.
  • If suspected or confirmed acute myocardial infarction as cause of acute heartfailure, patients can be recruited 5 days after hospitalization in the absence ofmalignant arrhythmias (e.g. ventricular tachycardia) or clinically significantresidual angina pectoris.

Study Design

Total Participants: 12
Study Start date:
February 01, 2020
Estimated Completion Date:
March 30, 2023

Connect with a study center

  • Aarhus University Hospital

    Aarhus, 8200
    Denmark

    Active - Recruiting

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