Treatment With the Ketone Body 3-hydroxybutyrate in Patients With Acute Heart Failure (KETO-AHF1)

July 14, 2022 updated by: Kristian Hylleberg Christensen, University of Aarhus

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Denmark
      • Aarhus, Denmark, 8200
        • Recruiting
        • Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 3-Hydroxybutyrate treatment
HVMN Ketone Ester 0,5 g / kg
Dietary supplement: HVMN Ketone Ester
Commercially available ketone supplement
PLACEBO_COMPARATOR: Placebo Treatment
Maltodextrin-base isocaloric placebo
Dietary supplement: Maltodextrin
Commercially available maltodextrin supplement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac Output (L/min)
Time Frame: 3 hours - Area under the curve
Right Heart Catherization
3 hours - Area under the curve
Left Ventricular Ejection Fraction
Time Frame: 3 hours - Area under the curve
Echocardiography
3 hours - Area under the curve

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Left Ventricular Outflow Tract Velocity Time Integral (cm)
Time Frame: 3 hours - Area under the curve
Echocardiography
3 hours - Area under the curve
Left Ventricular Filling Pressure (mmHg)
Time Frame: 3 hours - Area under the curve
Right Heart Catherization
3 hours - Area under the curve

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2020

Primary Completion (ANTICIPATED)

March 30, 2023

Study Completion (ANTICIPATED)

March 30, 2023

Study Registration Dates

First Submitted

June 18, 2020

First Submitted That Met QC Criteria

June 18, 2020

First Posted (ACTUAL)

June 22, 2020

Study Record Updates

Last Update Posted (ACTUAL)

July 18, 2022

Last Update Submitted That Met QC Criteria

July 14, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KETO-AHF1 1-10-72-59-19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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