CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 26 enrolled
Drug / intervention
Ketone ester +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04633460
NCT04633460Phase 2Completed

Acute Effects of Exogenous Ketone Ester Administration in Heart Failure

University of Pennsylvania·interventional·Posted Nov 18, 2020·Updated Nov 27, 2024

In Brief

A Phase 2 clinical trial evaluating Ketone ester and placebo drink for Heart Failure With Preserved Ejection Fraction. Completed, enrolled 26 participants across 1 site.

Detailed Summary

The purpose of this study is to test whether a ketone ester drink will improve exercise in people with heart failure (HF) compared to a placebo. In HF, patients are limited in their ability to do all the things they want to do, and exercise as much as they would like, due to becoming tired and short of breath early. There may be several reasons why these symptoms occur. There is some evidence that in addition to problems with the heart, patients with HF also have problems with their arteries and muscles that affect their ability to exercise. Ketones have been shown to improve exercise capacity in healthy volunteers, which may be related to effects on the heart function or on muscles. An infusion of ketones through an intravenous (IV) line has also been shown to significantly improve heart function, but whether a drink can produce similar improvements in HF patients is not known. This drink has been given status by Food and Drug Administration as "generally regarded as safe". The use of DeltaG in this study is experimental. DeltaG has not been approved by the Food and Drug Administration (FDA) for the use being evaluated in this study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedNov 18, 2020
Enrollment StartOct 6, 2020
Primary CompletionOct 4, 2023
Study CompletionOct 16, 2023
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 5.6 years ago

Interventions

Ketone esterdietary

A nutraceutical ketone ester (KE), (R)-3-hydroxybutyl (R)-3-hydroxybutyrate which provides systemic ketosis

placebo drinkdietary

KE free placebo drink