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Ketone Pharmacokinetic Study in HFrEF - Trial NCT05757193

Access comprehensive clinical trial information for NCT05757193 through Pure Global AI's free database. This Phase 1 trial is sponsored by Duke University and is currently Recruiting. The study focuses on Heart Failure With Reduced Ejection Fraction. Target enrollment is 20 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.

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NCT05757193
Phase 1
Recruiting
dietary supplement
Trial Details
ClinicalTrials.gov โ€ข NCT05757193
View on ClinicalTrials.gov
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Ketone Pharmacokinetic Study in HFrEF
Ketone Pharmacokinetic Study in Heart Failure With Reduced Ejection Fraction

Study Focus

DeltaG

Interventional

dietary supplement

Sponsor & Location

Duke University

Durham, United States of America

Timeline & Enrollment

Phase 1

May 15, 2023

May 01, 2024

20 participants

Primary Outcome

Venous pH,Glucose,Systolic blood pressure,Beta-hydroxybutyrate level

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.

ICD-10 Classifications

Heart failure
Congestive heart failure
Heart failure, unspecified
Hypertensive heart disease with (congestive) heart failure
Left ventricular failure

Data Source

ClinicalTrials.gov

NCT05757193

Non-Device Trial