Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-27 @ 10:50 PM
Study NCT ID:
NCT04379934
Status:
UNKNOWN
Last Update Posted:
2020-05-08
First Post:
2020-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Functional and Metabolic Effects of Ketone Bodies on Human Atrial Tissue in Patients With and Without Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D015427', 'term': 'Reperfusion Injury'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2024-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-05-04', 'studyFirstSubmitDate': '2020-04-30', 'studyFirstSubmitQcDate': '2020-05-04', 'lastUpdatePostDateStruct': {'date': '2020-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Contractile force recovery', 'timeFrame': 'Outcome will be assessed within a year when the inclusion of patients is complete', 'description': 'Atrial strips model, contractile force (nm\\*mm\\^-1) during stabilization, ischemia and reperfusion'}], 'secondaryOutcomes': [{'measure': 'Mitochondrial respiratory capacity', 'timeFrame': 'Outcome will be assessed within a year when the inclusion of patients is complete', 'description': 'High Resolution Respirometry, Complex I and Complex I+II respiration (pmol O2 · s-1·mg-1) assessed via a substrate and inhibitor (SUIT) protocol.'}, {'measure': 'Mitochondrial Reactive Oxygen Species production', 'timeFrame': 'Outcome will be assessed within a year when the inclusion of patients is complete', 'description': 'High Resolution FluoRespirometry, Complex I and Complex I+II linked ROS generation measured with AmplexUltra red and H2O2 interaction fluorescense'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Failure', 'Ischemia Reperfusion Injury', 'Mitochondrial Pathology']}, 'referencesModule': {'references': [{'pmid': '30884964', 'type': 'BACKGROUND', 'citation': 'Nielsen R, Moller N, Gormsen LC, Tolbod LP, Hansson NH, Sorensen J, Harms HJ, Frokiaer J, Eiskjaer H, Jespersen NR, Mellemkjaer S, Lassen TR, Pryds K, Botker HE, Wiggers H. Cardiovascular Effects of Treatment With the Ketone Body 3-Hydroxybutyrate in Chronic Heart Failure Patients. Circulation. 2019 Apr 30;139(18):2129-2141. doi: 10.1161/CIRCULATIONAHA.118.036459.'}]}, 'descriptionModule': {'briefSummary': 'This proof of concept study aims to evaluate the effects of applying ketone bodies to human atrial tissue biopsies using an atrial strips model and high resolution respirometry.', 'detailedDescription': 'Ketone bodies are high energy molecules which are naturally occurring in the body during fasting or stress.\n\nRecently, ketone bodies have been shown to improve cardiac function in patients with heart failure(1) through a mechanism, which has yet to be elaborated.\n\nWe wish to evaluate the effects of ketone body administration on cardiac tissue subjected to ischemia reperfusion injury. We will evaluate contractile force of the and the mitochondrial performance. Cardiac atrial tissue will be obtained from patients undergoing coronary artery bypass grafting (CABG) or valve replacement surgery. Patients will be recruited after signing an informed consent and allocated in heart failure / non-heart failure groups based on a clinical evaluation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* EF \\< / \\> 45%, hospitalized for elective CABG or heart valve surgery\n\nExclusion Criteria:\n\n* Myocardial infarction within 4 weeks, atrial fibrillation, medically treated thyroid disease, oral treatment with opioids.'}, 'identificationModule': {'nctId': 'NCT04379934', 'briefTitle': 'Functional and Metabolic Effects of Ketone Bodies on Human Atrial Tissue in Patients With and Without Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Functional and Metabolic Effects of Ketone Bodies on Human Atrial Tissue in Patients With and Without Heart Failure', 'orgStudyIdInfo': {'id': 'KetoCard01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Heart failure', 'description': 'Ejection fraction \\< 45%', 'interventionNames': ['Dietary Supplement: 3-hydroxybuturate']}, {'type': 'OTHER', 'label': 'Non-heart failure', 'description': 'Ejection fraction \\> 45%', 'interventionNames': ['Dietary Supplement: 3-hydroxybuturate']}], 'interventions': [{'name': '3-hydroxybuturate', 'type': 'DIETARY_SUPPLEMENT', 'description': '3-hydroxybuturate will be administered directly as a modified Krebs Henseleit buffer in a super perfused atrial strips model', 'armGroupLabels': ['Heart failure', 'Non-heart failure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8200', 'city': 'Aarhus', 'country': 'Denmark', 'contacts': [{'name': 'Jacob Seefeldt, M.B.', 'role': 'CONTACT', 'email': 'jacob.seefeldt@clin.au.dk', 'phone': '+45 4117633'}, {'name': 'Bent Roni Nielsen, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'bent.nils@midt.rm.dk', 'phone': '+45 51219363'}, {'name': 'Bent Roni Nielsen, M.D., PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jacob Seefeldt, M.B', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'centralContacts': [{'name': 'Jacob Seefeldt, B.M', 'role': 'CONTACT', 'email': 'jacob.seefeldt@clin.au.dk', 'phone': '+45 41178633'}, {'name': 'Bent Roni Nielsen, M.D., PhD.', 'role': 'CONTACT', 'email': 'bent.nils@midt.rm.dk', 'phone': '+45 51 21 93 63\u202c'}], 'overallOfficials': [{'name': 'Hans Erik Bøtker, M.D., Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Aarhus University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aarhus University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}