Trials / Enrolling By Invitation
Enrolling By InvitationNCT06937320
Chronic Exogenous Ketosis in HFpEF
Chronic Effects of Exogenous Ketone Administration in Heart Failure With Preserved Ejection Fraction
- Status
- Enrolling By Invitation
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- Sponsor
- Duke University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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).
Conditions
- Heart Failure With Preserved Ejection Fraction (HFPEF)
- Heart Failure With Normal Ejection Fraction
- Heart Failure, Diastolic
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Exogenous Ketone Drink | (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 |
| DIETARY_SUPPLEMENT | Placebo | equi-volume placebo administered for 8 weeks |
Timeline
- Start date
- 2025-07-28
- Primary completion
- 2027-06-01
- Completion
- 2027-06-01
- First posted
- 2025-04-22
- Last updated
- 2025-09-17
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06937320. Inclusion in this directory is not an endorsement.