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

NCT04443426 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2022-08-18

No results posted yet for this study

Summary

The ketone body 3-hydroxybutyrate (3-OHB) is a naturally occurring energy substrate, and is associated with increased life span and improved health. We have previously shown that intravenous 3-OHB treatment increases myocardial blood flow \> 70% in healthy humans and data from our group show that 3-OHB increases cardiac output by 40 % in patients with heart failure.

In this study the investigators aim to investigate:

1. If this effect is reproducible with a commercially available oral ketone supplements
2. The safety of commercially available ketone supplements in heart failure patients

Conditions

Interventions

DIETARY_SUPPLEMENT

Oral 3-hydroxybutyrate salts

Comercially available 3-hydroxybutyrate salts with 36 grams of 3-OHB salts three times daily.

DIETARY_SUPPLEMENT

Carbohydrate Placebo

Comercially available carbohydrate sports drink. The placebo dose is isocaloric to the 3-hydroxy butyrate dose.

DIETARY_SUPPLEMENT

Ketone Monoester

Commercially available ketone monoester in a dosage isocaloric to 3-OHB salts.

Sponsors & Collaborators

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Kristian H Christensen, MD · Aarhus Universitetshospital - Department of Cardiology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-25
Primary Completion
2022-11-01
Completion
2022-11-01

Countries

  • Denmark

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04443426 on ClinicalTrials.gov