Heart FailurePhase 2KETO-BDNCT05768100
Hemodynamic Effects of Modulating Circulating Ketone Bodies With 1,3-butanediol
A Phase 2 study testing 1,3-Butanediol in people with Heart Failure, run by Aarhus University Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- 1,3-Butanediol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Apr 2023to 1 Mar 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic HF: NYHA class II-III, LVEF <40%. Negative urine-HCG for women with childbearing potential. Age ≥18 years.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read more
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.
- Conditions
- Heart Failure
- Being tested
- 1,3-Butanediol, Placebo
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1,3-ButanediolDietary supplement
Also called Ketone-IQ (HVMN)
1,3-Butanediol
PlaceboDietary supplement
Isovolumic placebo
| Study group | Role | What they receive |
|---|---|---|
| 1,3-Butanediol | Experimental | Not described Receives: Dietary Supplement: 1,3-Butanediol |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac output
As measured by LVOT VTI and HR
Measured: 6 hours
Secondary outcomes (5)
Stroke volume
Measured: 6 hours
Heart rate
Measured: 6 hours
LVEF
Measured: 6 hours
Changes in circulating 3-OHB
Measured: 6 hours
Changes in FFA
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2023
- Study start1 Apr 2023
- Primary completion1 Sep 2023
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05768100
- Sponsor's protocol ID
- 1-10-72-8-23
- Acronym
- KETO-BD
- Status last verified
- Mar 2023
- First submitted
- 2 Mar 2023
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Guldbrandsen H, Gopalasingam N, Christensen KH, Horsdal OK, Nielsen R, Wiggers H, Berg-Hansen K. Cardiovascular and Metabolic Effects of Modulating Circulating Ketone Bodies With 1,3-Butanediol in Patients With Heart Failure With Reduced Ejection Fraction. J Am Heart Assoc. 2025 Jan 7;14(1):e038461. doi: 10.1161/JAHA.124.038461. Epub 2024 Dec 24.
PubMed 39719429
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Effects of Modulating Circulating Ketone Bodies With 1,3-butanediol
- ClinicalTrials.gov ID
- NCT05768100
- Acronym / sponsor ID
- KETO-BD / 1-10-72-8-23
- Conditions
- Heart Failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 14 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1,3-Butanediol | Experimental | Dietary Supplement: 1,3-Butanediol |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Chronic HF: NYHA class II-III, LVEF <40%. Negative urine-HCG for women with childbearing potential. Age ≥18 years.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1,3-ButanediolAlso: Ketone-IQ (HVMN)1,3-Butanediol | Dietary supplement | 1,3-Butanediol |
| PlaceboIsovolumic placebo | Dietary supplement | Placebo |
Primary outcome
Cardiac output
Time frame: 6 hours
As measured by LVOT VTI and HR
5 secondary outcomes
Stroke volume
Time frame: 6 hours
Heart rate
Time frame: 6 hours
LVEF
Time frame: 6 hours
Changes in circulating 3-OHB
Time frame: 6 hours
Changes in FFA
Time frame: 6 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Derived from this study: PubMed 39719429Guldbrandsen H, Gopalasingam N, Christensen KH, Horsdal OK, Nielsen R, Wiggers H, Berg-Hansen K. Cardiovascular and Metabolic Effects of Modulating Circulating Ketone Bodies With 1,3-Butanediol in Patients With Heart Failure With Reduced Ejection Fraction. J Am Heart Assoc. 2025 Jan 7;14(1):e038461. doi: 10.1161/JAHA.124.038461. Epub 2024 Dec 24.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 1,3-Butanediol in people with Heart Failure, run by Aarhus University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac output (time frame: 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05768100, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2024; AzTrials last refreshed its copy on 6 Nov 2026.