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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
20
(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
Duke University
Durham, North Carolina, United States
Maximal exercise capacity
Peak VO2 assessed by cardiopulmonary exercise testing
Time frame: 8 weeks
Respiratory exchange ratio
Respiratory exchange ratio (RER) during cardiopulmonary exercise testing at 25 watts
Time frame: 8 weeks
Vasodilatory reserve
Percent change in total peripheral resistance from rest to peak exercise
Time frame: 8 weeks
Left atrial volume index
Left atrial volume index measured by echocardiogram
Time frame: 8 weeks
Resting E/e'
Resting E/e' on echocardiogram
Time frame: 8 weeks
Heart failure-related health status
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.
Time frame: 8 weeks
NT-proBNP
N-terminal pro-B-type natriuretic peptide levels measured in peripheral blood.
Time frame: 8 weeks
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