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About
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).
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
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:
Primary purpose
Allocation
Interventional model
Masking
20 participants in 2 patient groups, including a placebo group
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Central trial contact
Clinical Research Coordinator
Data sourced from clinicaltrials.gov
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