Heart FailureNCT05651529
Acute Oral Ketones or Carbohydrate Supplement Modify Heart Function in Heart Failure?
A study testing exogenous ketone salt supplement and exogenous carbohydrate supplement in people with Heart Failure, run by Université de Sherbrooke at 2 sites in Canada.
Trial summary
Does oral intake of exogenous ketone salt improve heart function measured by cardiac MRI in heart failure compared to oral intake of a carbohydrate placebo? 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?
- exogenous ketone salt supplement and exogenous carbohydrate supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 2 sitesCanada
- Study dates
- 16 Dec 2022to 16 Dec 2025
- Phase
- Interventional
- 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
- Patients with heart failure with left ventricle ejection fraction of 40%
- Heart failure of ischemic or dilated etiology
- Ambulatory patient with a NYHA functional class of II-III;
- Stable symptoms and no change in medical therapy in the last month.
Who cannot join
- Diabetes
- Patients treated with any SGLT2i;
- Chronic kidney disease
- Acute coronary syndrome in the last 3 months;
- Use of parenteral inotropic agents;
- Persistent or permanent atrial fibrillation or atrial flutter;
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- Presence of pacemaker or defibrillator;
- Medical condition that causes malabsorption of the test material;
- Under ketogenic diet, or using exogenous ketone supplements
- Use of nicotinamide adenine dinucleotide (NAD) precursor supplements
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Centre Hospitalier Universitaire de Sherbrooke, departement de cardiologie
Sherbrooke, Quebec, J1H 5N4
Centre Hospitalier Universitaire de Sherbrooke, departement de médecine
Sherbrooke, Quebec, J1H 5N4
About this study
Official title: Does Oral Intake of Beta-hydroxybutyrate Decrease Left Ventricular End-systolic Volume at Cardiac Magnetic Resonance in Patients With Heart Failure Compared to Carbohydrate Placebo?
Does oral intake of exogenous ketone salt improve heart function measured by cardiac MRI in heart failure compared to oral intake of a carbohydrate placebo?
Read the detailed description
This study will help to quantify heart and kidney ketone uptake with or without an exogenous ketone salt in heart failure condition.
Participants will have 2 different cardiac MRI to perform:
- Fasting with exogenous ketone salt supplement
- Fasting with exogenous carbohydrate supplement
- Conditions
- Heart Failure
- Being tested
- exogenous ketone salt supplement, exogenous carbohydrate supplement
- Keywords
- Ketones, Heart
- Medical subject headings
- Heart Failure, Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exogenous ketone salt supplementDietary supplement
Also called Post-Prandial with exogenous ketone salt supplement
Dietary Supplement: Fasting water and with exogenous ketone salt supplement. Participants will have to take 1 doses of supplement 30 minutes before the scan.
exogenous carbohydrate supplementDietary supplement
Also called Post-Prandial with exogenous carbohydrate supplement
Dietary Supplement: Fasting water and with exogenous carbohydrate supplement. Participants will have to take 1 doses of supplement 30 minutes before the scan.
| Study group | Role | What they receive |
|---|---|---|
| Ketone | Active comparator | Not described Receives: Dietary Supplement: exogenous ketone salt supplement |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: exogenous carbohydrate supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricle ejection fraction by cardiac MRI under acute intake of exogenous ketone salt compared with exogenous carbohydrate placebo in heart failure patients.
Measure by Cardiac MR in pourcentage between diastolic and systolic volume in millimeter
Measured: 15 minutes
Secondary outcomes (11)
Right ventricle ejection fraction by cardiac MRI after intake supplement in heart failure patients.
Measure by Cardiac MR in pourcentage between diastolic and systolic volume in millimeter
Measured: 15 minutes
Ventricle volume by cardiac MRI after intake supplement in heart failure patients.
Measure by Cardiac MR in millimeter
Measured: 15 minutes
Cardiac output by cardiac MRI after intake supplement in heart failure patients.
Measure by Cardiac MR in liter per minute
Measured: 15 minutes
Effects of supplement on serum biomarkers
Concentration of lactate (mmol/L)
Measured: 60 minutes
Effects of supplement on serum biomarkers
Concentration sodium (mEq/L)
Measured: 60 minutes
Effects of supplement on serum biomarkers
Concentration of N-terminal pro-B-type natriuretic peptide (NT-proBNP) (pg/ml)
Measured: 60 minutes
Effects of supplement on serum biomarkers
Concentration of Beta-Hydroxybutyrate (mmol/L)
Measured: 60 minutes
Effects of supplement on serum biomarkers
Concentration of glucose (mmol/L)
Measured: 60 minutes
Effects of supplement on serum biomarkers
Concentration of insulin (IU)
Measured: 60 minutes
Effects of supplement on the blood pressure of heart failure patients
Measure the blood pressure in systole and diastole in mm Hg
Measured: 60 minutes
Effects of supplement on the heart rate of heart failure patients
Measure the heart rate in beat per minute
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2022
- Study start16 Dec 2022
- Primary completion16 Dec 2025
- Study completion16 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Crossover Assignment, Each participant will have to do the 2 Acute supplementation interventions
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Collaborators
- Nestlé Health Science
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05651529
- Sponsor's protocol ID
- 2023-4720
- Status last verified
- Jun 2025
- First submitted
- 29 Nov 2022
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Oral Intake of Beta-hydroxybutyrate Decrease Left Ventricular End-systolic Volume at Cardiac Magnetic Resonance in Patients With Heart Failure Compared to Carbohydrate Placebo?
- ClinicalTrials.gov ID
- NCT05651529
- Acronym / sponsor ID
- 2023-4720
- Conditions
- Heart Failure
- Keywords
- Ketones, Heart
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Collaborators
- Nestlé Health Science
- Study start
- 16 Dec 2022 (actual)
- Primary completion
- 16 Dec 2025 (actual)
- Study completion
- 16 Dec 2025 (actual)
- First posted
- 15 Dec 2022 (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.
Does oral intake of exogenous ketone salt improve heart function measured by cardiac MRI in heart failure compared to oral intake of a carbohydrate placebo?
Detailed description
This study will help to quantify heart and kidney ketone uptake with or without an exogenous ketone salt in heart failure condition.
Participants will have 2 different cardiac MRI to perform:
- Fasting with exogenous ketone salt supplement
- Fasting with exogenous carbohydrate supplement
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Crossover Assignment, Each participant will have to do the 2 Acute supplementation interventions
| Arm | Type | Receives |
|---|---|---|
| Ketone | Active comparator | Dietary Supplement: exogenous ketone salt supplement |
| Placebo | Placebo comparator | Dietary Supplement: exogenous carbohydrate supplement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with heart failure with left ventricle ejection fraction of 40%
- Heart failure of ischemic or dilated etiology
- Ambulatory patient with a NYHA functional class of II-III;
- Stable symptoms and no change in medical therapy in the last month.
Key exclusion criteria (10 listed)
- Diabetes
- Patients treated with any SGLT2i;
- Chronic kidney disease
- Acute coronary syndrome in the last 3 months;
- Use of parenteral inotropic agents;
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 |
|---|---|---|
| exogenous ketone salt supplementAlso: Post-Prandial with exogenous ketone salt supplementDietary Supplement: Fasting water and with exogenous ketone salt supplement. Participants will have to take 1 doses of supplement 30 minutes before the scan. | Dietary supplement | Ketone |
| exogenous carbohydrate supplementAlso: Post-Prandial with exogenous carbohydrate supplementDietary Supplement: Fasting water and with exogenous carbohydrate supplement. Participants will have to take 1 doses of supplement 30 minutes before the scan. | Dietary supplement | Placebo |
Primary outcome
Left ventricle ejection fraction by cardiac MRI under acute intake of exogenous ketone salt compared with exogenous carbohydrate placebo in heart failure patients.
Time frame: 15 minutes
Measure by Cardiac MR in pourcentage between diastolic and systolic volume in millimeter
11 secondary outcomes
Right ventricle ejection fraction by cardiac MRI after intake supplement in heart failure patients.
Time frame: 15 minutes
Ventricle volume by cardiac MRI after intake supplement in heart failure patients.
Time frame: 15 minutes
Cardiac output by cardiac MRI after intake supplement in heart failure patients.
Time frame: 15 minutes
Effects of supplement on serum biomarkers
Time frame: 60 minutes
Effects of supplement on serum biomarkers
Time frame: 60 minutes
Effects of supplement on serum biomarkers
Time frame: 60 minutes
Effects of supplement on serum biomarkers
Time frame: 60 minutes
Effects of supplement on serum biomarkers
Time frame: 60 minutes
Effects of supplement on serum biomarkers
Time frame: 60 minutes
Effects of supplement on the blood pressure of heart failure patients
Time frame: 60 minutes
Effects of supplement on the heart rate of heart failure patients
Time frame: 60 minutes
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 7 Jan 2026.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exogenous ketone salt supplement and exogenous carbohydrate supplement in people with Heart Failure, run by Université de Sherbrooke at 2 sites in Canada.
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 4 inclusion and 10 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 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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.
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?
Left ventricle ejection fraction by cardiac MRI under acute intake of exogenous ketone salt compared with exogenous carbohydrate placebo in heart failure patients. (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jan 2026.