Back to resultsPhysiological Effects Ketone Ester in Heart (KEHeart)
Primary Purpose
Heart Failure
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ketone Ester
Placebo
Sponsored by
About this trial
This is an interventional other trial for Heart Failure
Eligibility Criteria
Inclusion Criteria: heart failure EF < 40% Exclusion Criteria: Claustrophobia Contraindicated implanted device
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Ketone ester supplement
Arm Description
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.
Ketone ester given daily for 12 weeks and scanned before and after intervention with MRI.
Outcomes
Primary Outcome Measures
Change in Left Ventricular Ejection Fraction
Measured with cardiac MRI the left ventricular ejection fraction at two points and then delta is calculated
Secondary Outcome Measures
Change in Creatine concentration
Measured with cardiac MRI the creatine concentration at two points and then delta is calculated
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05924802
Brief Title
Physiological Effects Ketone Ester in Heart
Acronym
KEHeart
Official Title
Physiological Effects of Dietary Supplement Ketone Ester on the Heart
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
September 2028 (Anticipated)
Study Completion Date
September 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Placebo vs intervention group. Ketone ester is NOT a drug and only used to see the physiological effects on the heart.
Masking
ParticipantInvestigator
Masking Description
Both participant and investigators will be blinded. A representative in the center will be in charge of maintaining encrypted key.
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Ketone ester supplement
Arm Type
Experimental
Arm Description
Ketone ester given daily for 12 weeks and scanned before and after intervention with MRI.
Intervention Type
Dietary Supplement
Intervention Name(s)
Ketone Ester
Other Intervention Name(s)
delta G
Intervention Description
Added to water or lemonade 3 times per day.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Added to water or lemonade 3 times per day.
Primary Outcome Measure Information:
Title
Change in Left Ventricular Ejection Fraction
Description
Measured with cardiac MRI the left ventricular ejection fraction at two points and then delta is calculated
Time Frame
Pre-intervention and up to 12 weeks after intervention
Secondary Outcome Measure Information:
Title
Change in Creatine concentration
Description
Measured with cardiac MRI the creatine concentration at two points and then delta is calculated
Time Frame
Pre-intervention and up to 12 weeks after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
heart failure EF < 40%
Exclusion Criteria:
Claustrophobia
Contraindicated implanted device
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christopher Nguyen, PhD
Phone
2166365819
Email
circ@ccf.org
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33356362
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.
Results Reference
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PubMed Identifier
37268056
Citation
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.
Results Reference
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Learn more about this trial
Physiological Effects Ketone Ester in Heart
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