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_SUPPLEMENT
    500 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_SUPPLEMENT
    ketone-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: placebo
    KE-free solution

Primary Outcome Measure

Maximal exercise capacity [ Time Frame: 60 minutes after the intervention ]

Locations (1)

FacilityCityStateZIPSite coordinators
Duke UniversityDurhamNorth Carolina27710-

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