Ketones in Heart Failure With Reduced Ejection Fraction
Part of paid clinical trials in Durham, North Carolina.
- Sponsor
- Duke University
- Study ID
- NCT06195982
- Phase
- PHASE2
- Status
- Enrolling By Invitation
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- ketone ester — DIETARY_SUPPLEMENT500 mg/kg of ketone ester administered approximately 1 hour prior to the maximal exercise testing and 250 mg/kg administered approximately 30 minutes prior to submaximal exercise testing
- placebo — DIETARY_SUPPLEMENTketone-free placebo administered approximately 1 hour prior to the maximal exercise testing and ketone-free placebo administered approximately 30 minutes prior to submaximal exercise testing
Study Details
The purpose of this study is to understand the effects of a ketone drink on exercise capacity and other cardiovascular parameters in patients with heart failure. In heart failure, patients are limited in their ability to do all the things they want to do, and exercise as much as they would like, due to becoming tired and short of breath early. There may be several reasons why these symptoms occur. This study is assessing whether the ketone drink can improve these symptoms. This drink has been given status by Food and Drug Administration as "generally regarded as safe". The use of DeltaG in this study is experimental. DeltaG has not been approved by the Food and Drug Administration (FDA) for the use being evaluated in this study.
Key Dates
- Start date
- Mar 6, 2024
- Status verified
- Apr 2026
- Primary completion
- Oct 31, 2026
- Completion
- Oct 31, 2026
Study Design
- Enrollment
- 25 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- TREATMENT
Arms
- Experimental: ketone ester(R)-3-hydroxybutyl (R)-3-hydroxybutyrate, a ketone ester
- Placebo Comparator: placeboKE-free solution
Primary Outcome Measure
Maximal exercise capacity [ Time Frame: 60 minutes after the intervention ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Duke University | Durham | North Carolina | 27710 | - |
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