Could a ketone drink give heart failure patients a boost?
NCT ID NCT06195982
First seen Jun 25, 2026 · Last updated Sep 04, 2026 · Updated 6 times
Summary
This study tests whether a ketone drink can improve exercise ability in people with heart failure. Researchers will give 25 participants either the drink or a placebo before exercise tests. The goal is to see if the drink helps them exercise longer and with less shortness of breath.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ketone drink (ketone ester)
- What this could lead to
- If it works, this could point toward a simple dietary supplement to help heart failure patients exercise longer and feel less tired.
- What could go wrong
- This is a small, early-phase trial with only 25 people. The drink is experimental for this use, and results may not apply to all heart failure patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
25 people
The number who actually took part.
- Started
-
Mar 2024
- Finished
-
Aug 2026
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Stable cardiovascular medical therapy for 2 weeks 2. Participants will be required to have heart failure with reduced ejection fraction (left ventricular EF \</= 45%) and New York Heart Association (NYHA) class II or III symptoms. In cases of ambiguity of functional status, reduced peak VO2 (\<85% predicted VO2) at the baseline visit can be used to confirm reduced exercise tolerance. Exclusion Criteria: 1. Intentional ketogenic diet in the last week 2. Cirrhosis or significant alcohol consumption 3. Contraindications to stress testing, conditions that limit exercise, and other clinically-significant causes of exertional limitation (claudication with peripheral artery disease, atrial fibrillation and heart rate \>110 at rest, systolic blood pressure\>180 mmHg or diastolic blood pressure\>110 mmHg, infiltrative/hypertrophic cardiomyopathy, clinically significant pericardial disease, joint or neuromuscular disease that precludes exercise, acute coronary syndrome within the last 2 months, estimated glomerular filtration rate\<20 mL/min/1.73 m2, and hemoglobin \< 9 mg/dL). 4. Clinically significant lung disease: supplemental oxygen (aside from obstructive sleep apnea), chronic obstructive pulmonary disease requiring home oxygen or exacerbation within the last 2 months requiring steroids or antibiotics, severe obstructive lung disease (Gold stage 3). 5. \>/= Moderate aortic stenosis, \>mild mitral stenosis, \> moderate aortic or mitral regurgitation 6. Type 1 diabetes mellitus 7. Implant of cardiac resynchronization therapy, cardiac contractility modulation, or barostim device within the previous 3 months. 8. Systolic blood pressure \<90 mmHg 9. Pregnant women 10. Angina due to epicardial coronary disease or known presence of clinically-significant, unrevascularized epicardial coronary disease, in the investigator's opinion. 11. History of heart transplant, left ventricular assist device, or use of inotropic medication. 12. Participation in another clinical study with an investigational product in the previous 4 weeks prior to enrollment. 13. Conditions that may render the patient unable to complete the study
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Duke University
Durham, North Carolina, 27710, United States
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Other studies related to the condition(s) this trial covers.
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