Duke University
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).
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 peptid…
(R)-1,3-butanediol (BD, commercially available as "KetoneIQ") initially dosed 300 mg/kg BID (target dose 400 mg/kg grams BID if tolerated) for 8 weeks
equi-volume placebo administered for 8 weeks
Arctuva estimate
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