Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
Study NCT ID:
NCT05924802
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-24
First Post:
2023-06-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Physiological Effects Ketone Ester in Heart
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C524675', 'term': 'formic acid 4-(3-oxobutyl)phenyl ester'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Both participant and investigators will be blinded. A representative in the center will be in charge of maintaining encrypted key.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Placebo vs intervention group. Ketone ester is NOT a drug and only used to see the physiological effects on the heart.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2029-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-19', 'studyFirstSubmitDate': '2023-06-09', 'studyFirstSubmitQcDate': '2023-06-27', 'lastUpdatePostDateStruct': {'date': '2025-09-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Left Ventricular Ejection Fraction', 'timeFrame': 'Pre-intervention and up to 12 weeks after intervention', 'description': 'Measured with cardiac MRI the left ventricular ejection fraction at two points and then delta is calculated'}], 'secondaryOutcomes': [{'measure': 'Change in Creatine concentration', 'timeFrame': 'Pre-intervention and up to 12 weeks after intervention', 'description': 'Measured with cardiac MRI the creatine concentration at two points and then delta is calculated'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Failure']}, 'referencesModule': {'references': [{'pmid': '33356362', 'type': 'BACKGROUND', '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.'}, {'pmid': '37268056', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* heart failure EF \\< 40%\n\nExclusion Criteria:\n\n* Claustrophobia\n* Contraindicated implanted device'}, 'identificationModule': {'nctId': 'NCT05924802', 'acronym': 'KEHeart', 'briefTitle': 'Physiological Effects Ketone Ester in Heart', 'organization': {'class': 'OTHER', 'fullName': 'The Cleveland Clinic'}, 'officialTitle': 'Physiological Effects of Dietary Supplement Ketone Ester on the Heart', 'orgStudyIdInfo': {'id': '23-570'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', '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.', 'interventionNames': ['Dietary Supplement: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Ketone ester supplement', 'description': 'Ketone ester given daily for 12 weeks and scanned before and after intervention with MRI.', 'interventionNames': ['Dietary Supplement: Ketone Ester']}], 'interventions': [{'name': 'Ketone Ester', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['delta G'], 'description': 'Added to water or lemonade 3 times per day.', 'armGroupLabels': ['Ketone ester supplement']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Added to water or lemonade 3 times per day.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cardiovascular Innovation Research Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Cleveland Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Christopher Nguyen', 'investigatorAffiliation': 'The Cleveland Clinic'}}}}