Heart FailurePhase 2KETO-CHFNCT05161650
Hemodynamic Effects of Chronic Ketosis.
A Phase 2 study testing Ketone monoester (3-OHB) in people with Heart Failure, run by University of Aarhus at 1 site in Denmark.
Trial summary
Heart Failure (HF) is a major public health issue because the disease affects 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 13% and >50% of HF patients are admitted during a 2.5… 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?
- Ketone monoester (3-OHB)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Jan 2022to 1 Nov 2023
- 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 heart failure with NYHA II-III
- Left ventricular ejection fraction ≤40%
- Negative urine-HCG for women with childbearing potential
Who cannot join
- Known diabetes or HbA1c ≥48 mmol/mol
- Significant cardiac valve disease
- Severe stable angina pectoris
- Age <18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Modulation of Circulating Levels of the Ketone Body 3-hydroxybutyrate in Patients With Chronic Heart Failure: Cardiovascular Effects
Heart Failure (HF) is a major public health issue because the disease affects 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 13% and >50% of HF patients are admitted during a 2.5 year period. 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.
We have shown, using positron emission tomography, that ketone body infusion reduces myocardial glucose uptake and increases myocardial blood flow in healthy subjects. Data from another study conducted by our group show a 40% increase in cardiac output during infusion of 3-OHB in patients with HF and reduced left ventricular ejection fraction (HFrEF).
Read more
Presently there are no data on the clinical cardiovascular effects of long-term oral ketone-supplementation in patients with chronic HF.
In this study we aim to investigate the effect of 14 days modulation of circulating ketone body levels on cardiac function and exercise capacity in patients with HFrEF.
- Conditions
- Heart Failure
- Being tested
- Ketone monoester (3-OHB), Placebo drink
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketone monoester (3-OHB)Dietary supplement
Commercially available ketone supplement
Placebo drinkDietary supplement
Isocaloric placebo
| Study group | Role | What they receive |
|---|---|---|
| Ketone monoester (3-OHB) | Experimental | Not described Receives: Dietary Supplement: Ketone monoester (3-OHB) |
| Isocaloric placebo | Experimental | Not described Receives: Dietary Supplement: Placebo drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting cardiac output (L/min)
Measured with right heart catheterization
Measured: 14 days of dietary supplement
Secondary outcomes (4)
Resting pulmonary capillary wedge pressure (PCWP)
Measured with right heart catheterization
Measured: 14 days of dietary supplement
Peak exercise pulmonary capillary wedge pressure (PCWP)
Measured with right heart catheterization
Measured: 14 days of dietary supplement
Peak exercise cardiac output (L/min)
Measured with right heart catheterization
Measured: 14 days of dietary supplement
Exercise capacity (METs)
Cardiopulmonary exercise test
Measured: 14 days of dietary supplement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2021
- Study start15 Jan 2022
- Primary completion1 May 2023
- Study completion1 Nov 2023
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 University of AarhusThe 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristoffer Berg-Hansen, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05161650
- Sponsor's protocol ID
- KETO-CHF
- Acronym
- KETO-CHF
- Status last verified
- Nov 2023
- First submitted
- 3 Dec 2021
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Berg-Hansen K, Gopalasingam N, Christensen KH, Ladefoged B, Andersen MJ, Poulsen SH, Borlaug BA, Nielsen R, Moller N, Wiggers H. Cardiovascular Effects of Oral Ketone Ester Treatment in Patients With Heart Failure With Reduced Ejection Fraction: A Randomized, Controlled, Double-Blind Trial. Circulation. 2024 May 7;149(19):1474-1489. doi: 10.1161/CIRCULATIONAHA.123.067971. Epub 2024 Mar 27.
PubMed 38533643
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of Circulating Levels of the Ketone Body 3-hydroxybutyrate in Patients With Chronic Heart Failure: Cardiovascular Effects
- ClinicalTrials.gov ID
- NCT05161650
- Acronym / sponsor ID
- KETO-CHF / KETO-CHF
- Conditions
- Heart Failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 17 Dec 2021 (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 because the disease affects 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 13% and >50% of HF patients are admitted during a 2.5 year period. 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.
We have shown, using positron emission tomography, that ketone body infusion reduces myocardial glucose uptake and increases myocardial blood flow in healthy subjects. Data from another study conducted by our group show a 40% increase in cardiac output during infusion of 3-OHB in patients with HF and reduced left ventricular ejection fraction (HFrEF).
Presently there are no data on the clinical cardiovascular effects of long-term oral ketone-supplementation in patients with chronic HF.
In this study we aim to investigate the effect of 14 days modulation of circulating ketone body levels on cardiac function and exercise capacity in patients with HFrEF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketone monoester (3-OHB) | Experimental | Dietary Supplement: Ketone monoester (3-OHB) |
| Isocaloric placebo | Experimental | Dietary Supplement: Placebo drink |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chronic heart failure with NYHA II-III
- Left ventricular ejection fraction ≤40%
- Negative urine-HCG for women with childbearing potential
Key exclusion criteria (4 listed)
- Known diabetes or HbA1c ≥48 mmol/mol
- Significant cardiac valve disease
- Severe stable angina pectoris
- Age <18 years
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 |
|---|---|---|
| Ketone monoester (3-OHB)Commercially available ketone supplement | Dietary supplement | Ketone monoester (3-OHB) |
| Placebo drinkIsocaloric placebo | Dietary supplement | Isocaloric placebo |
Primary outcome
Resting cardiac output (L/min)
Time frame: 14 days of dietary supplement
Measured with right heart catheterization
4 secondary outcomes
Resting pulmonary capillary wedge pressure (PCWP)
Time frame: 14 days of dietary supplement
Peak exercise pulmonary capillary wedge pressure (PCWP)
Time frame: 14 days of dietary supplement
Peak exercise cardiac output (L/min)
Time frame: 14 days of dietary supplement
Exercise capacity (METs)
Time frame: 14 days of dietary supplement
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 30 Nov 2023.
- Derived from this study: PubMed 38533643Berg-Hansen K, Gopalasingam N, Christensen KH, Ladefoged B, Andersen MJ, Poulsen SH, Borlaug BA, Nielsen R, Moller N, Wiggers H. Cardiovascular Effects of Oral Ketone Ester Treatment in Patients With Heart Failure With Reduced Ejection Fraction: A Randomized, Controlled, Double-Blind Trial. Circulation. 2024 May 7;149(19):1474-1489. doi: 10.1161/CIRCULATIONAHA.123.067971. Epub 2024 Mar 27.
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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 Ketone monoester (3-OHB) in people with Heart Failure, run by University of Aarhus 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 3 inclusion and 4 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 30 Nov 2023. 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. 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?
Resting cardiac output (L/min) (time frame: 14 days of dietary supplement). 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 NCT05161650, 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 30 Nov 2023.