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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Ketone ester supplement | Experimental | Ketone ester given daily for 12 weeks and scanned before and after intervention with MRI. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketone Ester | Dietary Supplement | Added to water or lemonade 3 times per day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiovascular Innovation Research Center | Cleveland | Ohio | 44195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33356362 | Background | 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. | |
| 37268056 |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C524675 | formic acid 4-(3-oxobutyl)phenyl ester |
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Placebo vs intervention group. Ketone ester is NOT a drug and only used to see the physiological effects on the heart.
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Both participant and investigators will be blinded. A representative in the center will be in charge of maintaining encrypted key.
| Placebo | Dietary Supplement | Added to water or lemonade 3 times per day. |
|
| 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. |