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NCT05924802 Clinical Trial

Physiological Effects Ketone Ester in Heart

Heart Failure Clinical Trial

— KEHeart  

Official title:
Physiological Effects of Dietary Supplement Ketone Ester on the Heart

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05924802
Other study ID # 23-570
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 2024
Est. completion date September 2029

Study information
Verified date February 2024
Source The Cleveland Clinic
Contact Christopher Nguyen, PhD
Phone 2166365819
Email circ@ccf.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 50
Est. completion date September 2029
Est. primary completion date September 2028
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - heart failure EF < 40% Exclusion Criteria: - Claustrophobia - Contraindicated implanted device

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Ketone Ester
Added to water or lemonade 3 times per day.
• Placebo
Added to water or lemonade 3 times per day.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
The Cleveland Clinic

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Change in Creatine concentration Measured with cardiac MRI the creatine concentration at two points and then delta is calculated Pre-intervention and up to 12 weeks after intervention
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