Hemodynamic Effects of Chronic Ketosis. (KETO-CHF)

November 29, 2023 updated by: Kristoffer Berg-Hansen, University of Aarhus

Modulation of Circulating Levels of the Ketone Body 3-hydroxybutyrate in Patients With Chronic Heart Failure: Cardiovascular Effects

Heart Failure (HF) is a major public health issue because the disease affects 1-2% of the Western population and the lifetime risk of HF is 20%. Despite major improvements in the management and care of patients with HF, the 1-year mortality in patients with HF is 13% and >50% of HF patients are admitted during a 2.5 year period. Furthermore, patients with HF have markedly decreased physical capacity and quality of life. Thus, there is a need for new treatment modalities in this group of patients.

We have shown, using positron emission tomography, that ketone body infusion reduces myocardial glucose uptake and increases myocardial blood flow in healthy subjects. Data from another study conducted by our group show a 40% increase in cardiac output during infusion of 3-OHB in patients with HF and reduced left ventricular ejection fraction (HFrEF).

Presently there are no data on the clinical cardiovascular effects of long-term oral ketone-supplementation in patients with chronic HF.

In this study we aim to investigate the effect of 14 days modulation of circulating ketone body levels on cardiac function and exercise capacity in patients with HFrEF.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 2

Contacts and Locations

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

Study Locations

  • Denmark
      • Aarhus, Denmark, DK-8200
        • 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

Description

Inclusion Criteria:

  • Chronic heart failure with NYHA II-III
  • Left ventricular ejection fraction ≤40%
  • Negative urine-HCG for women with childbearing potential

Exclusion Criteria:

  • Known diabetes or HbA1c ≥48 mmol/mol
  • Significant cardiac valve disease
  • Severe stable angina pectoris
  • Age <18 years

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 Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ketone monoester (3-OHB)
Dietary supplement: Ketone monoester (3-OHB)
Commercially available ketone supplement
Experimental: Isocaloric placebo
Dietary supplement: Placebo drink
Isocaloric placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resting cardiac output (L/min)
Time Frame: 14 days of dietary supplement
Measured with right heart catheterization
14 days of dietary supplement

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resting pulmonary capillary wedge pressure (PCWP)
Time Frame: 14 days of dietary supplement
Measured with right heart catheterization
14 days of dietary supplement
Peak exercise pulmonary capillary wedge pressure (PCWP)
Time Frame: 14 days of dietary supplement
Measured with right heart catheterization
14 days of dietary supplement
Peak exercise cardiac output (L/min)
Time Frame: 14 days of dietary supplement
Measured with right heart catheterization
14 days of dietary supplement
Exercise capacity (METs)
Time Frame: 14 days of dietary supplement
Cardiopulmonary exercise test
14 days of dietary supplement

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)

January 15, 2022

Primary Completion (Actual)

May 1, 2023

Study Completion (Actual)

November 1, 2023

Study Registration Dates

First Submitted

December 3, 2021

First Submitted That Met QC Criteria

December 3, 2021

First Posted (Actual)

December 17, 2021

Study Record Updates

Last Update Posted (Actual)

November 30, 2023

Last Update Submitted That Met QC Criteria

November 29, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KETO-CHF

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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