NCT05768100: KETO-BD

Hemodynamic Effects of Modulating Circulating Ketone Bodies With 1,3-butanediol

Completed Phase 2 Last updated 22 March 2024

What this trial tests

Phase 2 trial testing 1,3-Butanediol in Heart Failure in 12 participants. Completed in 1 March 2024.

Timeline

1 April 2023

Primary endpoint
1 September 2023

1 March 2024

Quick facts

Lead sponsor	Aarhus University Hospital
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	treatment
Enrollment	12
Start date	1 April 2023
Primary completion	1 September 2023
Estimated completion	1 March 2024
Sites	1 location across Denmark

Drugs / interventions tested

• 1,3-Butanediol
• Placebo

Conditions studied

• Heart Failure — all drugs for Heart Failure →

Sponsor

Aarhus University Hospital

Who can join

18 and older, any sex, with Heart Failure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Heart Failure (HF) is a major public health issue affecting 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 high. 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.

In a first-in-man study we have recently discovered that 3-OHB-infusion increases cardiac output by 2 L/min (40% relative increase) and left ventricular (LV) ejection fraction (LVEF) by 8% in absolute numbers in patients with HF and reduced LVEF (HFrEF).

1,3-Butanediol (BD) serves as a potential nutritional supplement in providing long-lasting ketosis as a treatment option in heart disease. Whether BD provides similar hemodynamic effects as ketone monoester remains unknown.

Hypothesis Oral BD increases cardiac output and LV function in patients with HFrEF.

Aims To investigate the acute hemodynamic effects of weight-adjusted oral BD supplements in patients with HFrEF.

Design In a randomized, single-blind, placebo-controlled, crossover design, 12 patients with HFrEF are studied following overnight fast on 2 separate visits in random order: 1) during intake of BD (HVMN, San Francisco, California, USA) and during placebo.

Methods Transthoracic echocardiography, non-invasive blood pressure, and venous blood samples are obtained every 60 minutes from baseline until 6 hours following BD ingestion.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.