Physiological Effects Ketone Ester in Heart

NCT05924802 | Active Not Recruiting

• 1 other identifier: 23-570
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Change in Left Ventricular Ejection Fraction

  Measured with cardiac MRI the left ventricular ejection fraction at two points and then delta is calculated

  Pre-intervention and up to 12 weeks after intervention

Secondary Outcomes (1)

• Change in Creatine concentration

  Pre-intervention and up to 12 weeks after intervention

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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.

Dietary Supplement: Placebo

Ketone ester supplement

EXPERIMENTAL

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

Dietary Supplement: Ketone Ester

Interventions

Ketone Ester DIETARY_SUPPLEMENT

Added to water or lemonade 3 times per day.

Also known as: delta G

Ketone ester supplement

Placebo DIETARY_SUPPLEMENT

Added to water or lemonade 3 times per day.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• heart failure EF \< 40%

You may not qualify if:

• Claustrophobia
• Contraindicated implanted device

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cardiovascular Innovation Research Center

Cleveland, Ohio, 44195, United States

Location

Related Publications (2)

• 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.

  PMID: 33356362 BACKGROUND

• 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.

  PMID: 37268056 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Interventions

formic acid 4-(3-oxobutyl)phenyl ester

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Both participant and investigators will be blinded. A representative in the center will be in charge of maintaining encrypted key.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Model Details: Placebo vs intervention group. Ketone ester is NOT a drug and only used to see the physiological effects on the heart.

Study Record Dates

• First Submitted: June 9, 2023
• First Posted: June 29, 2023
• Study Start: June 1, 2024
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2029
• Last Updated: September 24, 2025

Record last verified: 2025-09

Locations

US (1)