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ENROLLING BY INVITATION
NCT06937320
PHASE2

Chronic Exogenous Ketosis in HFpEF

Sponsor: Duke University

View on ClinicalTrials.gov

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).

Official title: Chronic Effects of Exogenous Ketone Administration in Heart Failure With Preserved Ejection Fraction

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2025-07-28

Completion Date

2027-06

Last Updated

2025-09-17

Healthy Volunteers

No

Interventions

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

Locations (1)

Duke University

Durham, North Carolina, United States