Status:
ENROLLING_BY_INVITATION
Chronic Exogenous Ketosis in HFpEF
Lead Sponsor:
Duke University
Conditions:
Heart Failure With Preserved Ejection Fraction (HFPEF)
Heart Failure With Normal Ejection Fraction
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 functio...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 18 years of age or older
- Stable medical therapy for at least 2 weeks
- New York Heart Association (NYHA) class symptoms II or III
- Left ventricular ejection fraction ≥ 50%
- 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:
- 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.
Exclusion
Key Trial Info
Start Date :
July 28 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06937320
Start Date
July 28 2025
End Date
June 1 2027
Last Update
September 17 2025
Active Locations (1)
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1
Duke University
Durham, North Carolina, United States, 27710