Physiological Effects Ketone Ester in Heart

NCT ID: NCT05924802

Last Updated: 2025-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-01

Study Completion Date

2029-09-30

Brief Summary

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The study is aimed to phenotype with cardiac MRI the physiological effects of ketone esters on the heart. Patients with heart failure will be recruited and given ketone esters or placebo in a randomized fashion. Cardiac MRI will be performed at baseline and after 12weeks follow up.

Detailed Description

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Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Placebo vs intervention group. Ketone ester is NOT a drug and only used to see the physiological effects on the heart.
Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators
Both participant and investigators will be blinded. A representative in the center will be in charge of maintaining encrypted key.

Study Groups

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Placebo

Placebo given that mimics taste, weight, and size of the interventional supplement mirroring the same time points as the ketone ester supplement group. Mirrored imaging with MRI as well.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Added to water or lemonade 3 times per day.

Ketone ester supplement

Ketone ester given daily for 12 weeks and scanned before and after intervention with MRI.

Group Type EXPERIMENTAL

Ketone Ester

Intervention Type DIETARY_SUPPLEMENT

Added to water or lemonade 3 times per day.

Interventions

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Ketone Ester

Added to water or lemonade 3 times per day.

Intervention Type DIETARY_SUPPLEMENT

Placebo

Added to water or lemonade 3 times per day.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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delta G

Eligibility Criteria

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Inclusion Criteria

* heart failure EF \< 40%

Exclusion Criteria

* Claustrophobia
* Contraindicated implanted device
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

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Christopher Nguyen

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cardiovascular Innovation Research Center

Cleveland, Ohio, United States

Site Status

Countries

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United States

References

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Yurista SR, Matsuura TR, Sillje HHW, Nijholt KT, McDaid KS, Shewale SV, Leone TC, Newman JC, Verdin E, van Veldhuisen DJ, de Boer RA, Kelly DP, Westenbrink BD. Ketone Ester Treatment Improves Cardiac Function and Reduces Pathologic Remodeling in Preclinical Models of Heart Failure. Circ Heart Fail. 2021 Jan;14(1):e007684. doi: 10.1161/CIRCHEARTFAILURE.120.007684. Epub 2020 Dec 28.

Reference Type BACKGROUND
PMID: 33356362 (View on PubMed)

Yurista SR, Eder RA, Welsh A, Jiang W, Chen S, Foster AN, Mauskapf A, Tang WHW, Hucker WJ, Coll-Font J, Rosenzweig A, Nguyen CT. Ketone ester supplementation suppresses cardiac inflammation and improves cardiac energetics in a swine model of acute myocardial infarction. Metabolism. 2023 Aug;145:155608. doi: 10.1016/j.metabol.2023.155608. Epub 2023 Jun 1.

Reference Type BACKGROUND
PMID: 37268056 (View on PubMed)

Other Identifiers

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23-570

Identifier Type: -

Identifier Source: org_study_id

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