KETO-BHBD: Hemodynamic Effects of Modulating Circulating Ketone Bodies With Bis Hexanoyl (R)-1,3-butanediol
Study Details
Study Description
Brief 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).
Bis-Hexanoyl (R)-1,3-Butanediol (BH-BD) serves as a potential nutritional supplement in providing long-lasting ketosis as a treatment option in heart disease. Whether BH-BD provides similar hemodynamic effects as ketone monoester remains unknown.
Hypothesis Oral BH-BD increases cardiac output and LV function in patients with HFrEF.
Aims To investigate the acute hemodynamic effects of weight-adjusted oral BH-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 BH-BD (HVMN, San Francisco, California, USA) and during placebo.
Methods Transthoracic echocardiography, non-invasive blood pressure, and venous blood samples are obtained every 60 hours from baseline until 6 hours following BH-BD ingestion.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Bis-Hexanoyl (R)-1,3-Butanediol
|
Dietary Supplement: Bis-Hexanoyl (R)-1,3-Butanediol
Bis-Hexanoyl (R)-1,3-Butanediol
Other Names:
|
| Placebo Comparator: Placebo
|
Dietary Supplement: Placebo
Isovolumic placebo
|
Outcome Measures
Primary Outcome Measures
- Cardiac output [6 hours]
As measured by LVOT VTI and HR
Secondary Outcome Measures
- Stroke volume [6 hours]
- Heart rate [6 hours]
- LVEF [6 hours]
- Changes in circulating 3-OHB [6 hours]
- Changes in FFA [6 hours]
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Aarhus University Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1-10-72-8-23