Chronic Exogenous Ketosis in HFpEF

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT06937320
Phase
PHASE2
Status
Enrolling By Invitation

Conditions

  • Heart Failure With Normal Ejection Fraction
  • Heart Failure With Preserved Ejection Fraction (HFPEF)
  • Heart Failure, Diastolic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Exogenous Ketone Drink — DIETARY_SUPPLEMENT
    (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
  • Placebo — DIETARY_SUPPLEMENT
    equi-volume placebo administered for 8 weeks

Study Details

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).

Key Dates

Start date
Jul 28, 2025
Status verified
Sep 2025
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Exogenous ketone drink
    (R)-1,3-butanediol (commercially obtained as "KetoneIQ")
  • Placebo Comparator: Placebo
    ketone-free solution

Primary Outcome Measure

Maximal exercise capacity [ Time Frame: 8 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Duke UniversityDurhamNorth Carolina27710-

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