NCT05768100CompletedPhase 2
Hemodynamic Effects of Modulating Circulating Ketone Bodies With 1,3-butanediol
Source: ClinicalTrials.gov · Last updated 22 Mar 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 12 (actual)
- First submitted
- 2 Mar 2023
- Start date
- Apr 2023
- Primary completion date
- Sept 2023
- Lead sponsor
- Aarhus University Hospital
- Diseases
- Heart failure
- NCT number
- NCT05768100
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 12
- From Apr 2023 to the primary completion date, Sept 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- 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.
Who the study is looking for
- Chronic HF: NYHA class II-III, LVEF \<40%. Negative urine-HCG for women with childbearing potential. Age ≥18 years.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dept. of Cardiology, Aarhus University Hospital Coordinator of this site? Confirm its status | Aarhus | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.