NCT05757193

Ketone Pharmacokinetic Study in HFrEF

Ketone Pharmacokinetic Study in Heart Failure With Reduced Ejection Fraction

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test whether an over-the-counter ketone ester drink is well tolerated in people with heart failure on, and not on, a heart failure medication class called SGLT2 inhibitors. The research team is trying to determine the safest dose of Delta G. The study has a single visit. Participants will be served a light breakfast with the study drink, a physical exam will be conducted, and the study team will obtain information about demographics and medical history. The study team will draw blood intravenously up to eight times over the course of the half-day visit.

Conditions

• Heart Failure With Reduced Ejection Fraction

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	DeltaG (250 mg/kg)	250 mg/kg of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate
DIETARY_SUPPLEMENT	DeltaG (500 mg/kg)	500 mg/kg of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate

Timeline

• Start date: 2023-06-02
• Primary completion: 2024-01-11
• Completion: 2024-01-11
• First posted: 2023-03-07
• Last updated: 2024-12-27
• Results posted: 2024-12-27

Locations

1 site across 1 country: United States