Acute Effects of Exogenous Ketone Ester Administration in Heart Failure

Phase 2

Completed

• Conditions: Heart Failure With Preserved Ejection Fraction
• Interventions: Dietary Supplement: Ketone ester; Dietary Supplement: placebo drink

• Registration Number: NCT04633460
• Lead Sponsor: University of Pennsylvania

Brief 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.

Detailed Description

This is a randomized, crossover trial of ketone ester versus placebo in 20 patients with heart failure with preserved ejection fraction. Participants come for a baseline assessment. If they meet eligibility criteria, they are randomized to receive ketone ester first or placebo first. After approximately a week washout period, participants return for the last visit to receive the product they did not receive at the previous visit.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-10-06
• Study First Submitted: 2020-10-23
• Study First Submitted QC: 2020-11-11
• Study First Posted: 2020-11-18
• Primary Completion: 2023-10-04
• Study Completion: 2023-10-16
• Results First Submitted: 2024-10-07
• Status Verified: 2024-11
• Results First Submitted QC: 2024-11-06
• Last Update Submitted: 2024-11-06
• Results First Posted: 2024-11-27
• Last Update Posted: 2024-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Ketone ester	Ketone ester	(R)-3-hydroxybutyl (R)-3-hydroxybutyrate, a ketone ester
Placebo	placebo drink	KE-free solution

Primary Outcome Measures

Name	Time	Method
Maximal Exercise Capacity (Peak VO2) Assessed by Cardiopulmonary Exercise Testing	Assessed 60 minutes after the intervention.	Peak VO2
Submaximal Exercise Capacity (Exercise Time at 75% of Peak Workload) Assessed by Cardiopulmonary Exercise Testing.	Assessed 30 minutes after the intervention.	Exercise time at 75% of peak workload

Secondary Outcome Measures

Name	Time	Method
Percent Change in Systemic Vascular Resistance With Exercise	Assessed 60 minutes after the intervention.	Percent change in systemic vascular resistance with exercise
Substrate Utilization (Reflected by the Respiratory Exchange Ratio) Assessed by Cardiopulmonary Exercise Testing.	Assessed 60 minutes after the intervention.
VO2 Efficiency (Total Work Performed Over Oxygen Consumed) During Submaximal Cardiopulmonary Exercise Testing.	Assessed 60 minutes after the intervention.
Presence of Exercise-induced Arrhythmias (Significant Atrial or Ventricular Arrhythmias)	Assessed throughout the study visit date after the intervention is given (until leaving the research study center that day).

Trial Locations

Locations (1)

Penn Presbyterian Medical Center; 🇺🇸 Philadelphia, Pennsylvania, United States