Chronic Exogenous Ketosis in HFpEF

Launched by DUKE UNIVERSITY · Apr 15, 2025

Keywords

ClinConnect Summary

This clinical trial, titled "Chronic Exogenous Ketosis in HFpEF," is exploring how a special ketone drink might help people with heart failure, specifically those whose heart function is still preserved (HFpEF). Many individuals with this condition find it hard to exercise, so the researchers want to see if drinking this ketone drink can improve their ability to be active and enhance their heart health. The study involves three visits: the first is to check if participants qualify for the trial, and the next two visits occur after they have consumed either the ketone drink or a placebo (a non-active drink) over 8 weeks.

To be eligible for this trial, participants need to be at least 18 years old and have stable heart failure symptoms. Specifically, they should have a left ventricular ejection fraction of 50% or more, indicating that their heart can still pump blood effectively. Participants must also meet other specific health criteria but should not have been on a strict ketogenic diet recently or have certain serious health conditions. During the trial, participants will be monitored closely, and their exercise capacity and heart function will be assessed to see if the ketone drink makes a difference. This study is not yet recruiting participants, so there's still time to learn more if you or a loved one are interested.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• • 1. 18 years of age or older
• • 2. Stable medical therapy for at least 2 weeks
• • 3. New York Heart Association (NYHA) class symptoms II or III
• • 4. Left ventricular ejection fraction ≥ 50%
• 5. Evidence for elevated filling pressures as follows (at least one of the following between a-d):
• a. Mitral early (E)/mitral septal tissue annular (e') velocity ratio \> 8 on echocardiography in addition to one of the following:
• • i. Enlarged left atrium (LA\>4.0 cm width or LA volume index \>34 mL/m2)
• • ii. Chronic loop diuretic use for control of symptoms
• • iii. Elevated natriuretic peptides within the past year (NT-proBNP\>125 pg/ml or BNP\>35 pg/ml)
• • b. Mitral E/e' ratio \> 14 at rest or with exercise on echocardiography
• • c. Elevated invasively-determined filling pressures previously (resting left ventricular end-diastolic pressure \>16 mm Hg or pulmonary capillary wedge pressure \> 14 mmHg; or PCWP or LVEDP ≥ 25 mmHg with exercise)
• • d. Prior episode of acute heart failure requiring IV diuretics with evidence of volume overload on exam or radiology, or evidence of elevated natriuretic peptides.
• Exclusion Criteria:
• • 1. Intentional ketogenic (high fat, low carbohydrate) diet in the last week
• • 2. Cirrhosis or alcohol use disorder (\>14 drinks/week).
• • 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/inflammatory 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, defined as severe obstructive lung disease (Gold stage 3), a requirement for supplemental oxygen, or chronic obstructive pulmonary disease with an exacerbation requiring steroids or antibiotics within the last 2 months.
• • 5. \> Moderate aortic stenosis, \>mild mitral stenosis, \> moderate aortic or mitral regurgitation on screening echocardiogram, or presence of a prosthetic valve in the mitral position.
• • 6. Type 1 diabetes mellitus
• • 7. Start of a GLP-1 RA within the past 6 months.
• • 8. Pregnant women.
• • 9. Angina due to epicardial coronary disease or known presence of clinically-significant, unrevascularized epicardial coronary disease, in the investigator's opinion.
• • 10. Prior reduced LVEF to \< 45% by echocardiography or cardiac MRI
• • 11. Participation in another clinical study with an investigational product in the previous 4 weeks prior to enrollment (or longer if deemed necessary by the investigator).
• • 12. Conditions that may render the patient unable to complete the study, in the opinion of the investigator.