Chronic Exogenous Ketosis in HFpEF
- Conditions
- Heart Failure With Preserved Ejection Fraction (HFPEF)Heart Failure With Normal Ejection FractionHeart Failure, Diastolic
- Registration Number
- NCT06937320
- Lead Sponsor
- Duke University
- Brief Summary
The goal of this clinical research study is to test what effects a ketone drink will have in people with heart failure with preserved ejection fraction (HFpEF), including on exercise and heart function. Patients with HFpEF often have difficulty exercising, and our goal is to understand whether a ketone drink changes much patients can exercise. The study has three visits, including a baseline visit to assess for study eligibility, and two visits (one after 8 weeks of a ketone drink or a placebo drink, and another one after 8 weeks of whichever drink the participant did not receive the first time).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 20
Not provided
- Intentional ketogenic (high fat, low carbohydrate) diet in the last week
- Cirrhosis or alcohol use disorder (>14 drinks/week).
- 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).
- 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.
- > Moderate aortic stenosis, >mild mitral stenosis, > moderate aortic or mitral regurgitation on screening echocardiogram, or presence of a prosthetic valve in the mitral position.
- Type 1 diabetes mellitus
- Start of a GLP-1 RA within the past 6 months.
- Pregnant women.
- Angina due to epicardial coronary disease or known presence of clinically-significant, unrevascularized epicardial coronary disease, in the investigator's opinion.
- Prior reduced LVEF to < 45% by echocardiography or cardiac MRI
- 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).
- Conditions that may render the patient unable to complete the study, in the opinion of the investigator.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Maximal exercise capacity 8 weeks Peak VO2 assessed by cardiopulmonary exercise testing
- Secondary Outcome Measures
Name Time Method Respiratory exchange ratio 8 weeks Respiratory exchange ratio (RER) during cardiopulmonary exercise testing
Pulse wave velocity 8 weeks Pulse wave velocity measured during arterial tonometry
Left atrial volume index 8 weeks Left atrial volume index measured by echocardiogram
Resting E/e' 8 weeks Resting E/e' on echocardiogram
Heart failure-related health status 8 weeks Heart failure-related health status using Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ-OSS). Score range is from 0 to 100, with higher scores indicating better health status and lower scores indicating poorer health status.
NT-proBNP 8 weeks N-terminal pro-B-type natriuretic peptide levels measured in peripheral blood.
Trial Locations
- Locations (1)
Duke University
🇺🇸Durham, North Carolina, United States