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

Heart Failure Clinical Trial

— KETO-BD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05768100
• Other study ID #: 1-10-72-8-23
• Status: Completed
• Phase: Phase 2
• Start date: April 1, 2023
• Est. completion date: March 1, 2024

Study information

• Verified date: March 2023
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 1, 2024
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Chronic HF: NYHA class II-III, LVEF <40%. Negative urine-HCG for women with childbearing potential. Age =18 years.

Exclusion Criteria:

• Diabetes or HbA1c >48 mmol/mol, significant cardiac valve disease, severe stable angina pectoris, severe comorbidity as judged by the investigator, inability to give informed consent.

Related Conditions & MeSH terms

• Heart Failure

Intervention

Dietary Supplement:
• 1,3-Butanediol
1,3-Butanediol
• Placebo
Isovolumic placebo

Locations

Country	Name	City	State
Denmark	Dept. of Cardiology, Aarhus University Hospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac output	As measured by LVOT VTI and HR	6 hours
Secondary	Stroke volume		6 hours
Secondary	Heart rate		6 hours
Secondary	LVEF		6 hours
Secondary	Changes in circulating 3-OHB		6 hours
Secondary	Changes in FFA		6 hours