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Ketone Pharmacokinetic Study in HFrEF

NCT05757193 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-12-27

Study results available
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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

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

Sponsors & Collaborators

Principal Investigators

  • Senthil Selvaraj, MD, MSTR, MA · Duke University

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-02
Primary Completion
2024-01-11
Completion
2024-01-11

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05757193 on ClinicalTrials.gov