Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2026-04-24 @ 3:55 AM
Study NCT ID:
NCT03073356
Status:
COMPLETED
Last Update Posted:
2017-12-11
First Post:
2017-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ketones in Heart Failure - Effects on Cardiac Efficiency
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054143', 'term': 'Heart Failure, Systolic'}, {'id': 'D007662', 'term': 'Ketosis'}], 'ancestors': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000138', 'term': 'Acidosis'}, {'id': 'D000137', 'term': 'Acid-Base Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Randomized dobbel-blinded crossover'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2017-11-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-08', 'studyFirstSubmitDate': '2017-02-20', 'studyFirstSubmitQcDate': '2017-03-02', 'lastUpdatePostDateStruct': {'date': '2017-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Myocardial efficiency', 'timeFrame': '1 day', 'description': 'Based on myocardial PET examinations'}, {'measure': 'Cardiac output', 'timeFrame': '1 day', 'description': 'Right sided heart catheterization'}], 'secondaryOutcomes': [{'measure': 'Myocardial perfusion', 'timeFrame': '1 day', 'description': 'Based on myocardial PET examinations'}, {'measure': 'Myocardial oxygen consumption', 'timeFrame': '1 day', 'description': 'Based on myocardial PET examinations'}, {'measure': 'Pulmonary and wedge pressure', 'timeFrame': '1 day', 'description': 'Right sided heart catheterization'}, {'measure': 'Mixed venous saturation', 'timeFrame': '1 day', 'description': 'Right sided heart catheterization'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Myocardial metabolism', 'Positron emission tomography', 'Echocardiography', 'Right sided heart catheterization'], 'conditions': ['Heart Failure, Systolic', 'Ketonemia']}, 'descriptionModule': {'briefSummary': 'Ketones may have beneficial effects on myocardial metabolism and hemodynamics. In the present study, healthy test subjects and patients with heart failure with reduced ejections fraction will be investigated in a randomized cross-over design with ketone infusions and placebo. Myocardial efficiency and hemodynamics will be evaluated.', 'detailedDescription': 'The prevalence of patients with heart failure and reduced ejection fraction (HFrEF) is 1-2%, and the lifetime risk of heart failure at age 55 years is approximately 30%. Despite advances in treatment, hospitalization rate and mortality remains high. It is well known that myocardial metabolism changes during development of HFrEF, and may contribute to contractile dysfunction. However, the myocardium can be considered an omnivore regarding substrate utilization, conferring an important adaptive property. Hence, it metabolizes either glucose, lipids, lactate, amino acids or ketones (3-hydroxybutyrate) depending on substrate availability, hormonal status and cardiac demands. These substrates differ with regard to myocardial energy efficiency (MEE) (cardiac work related to oxygen consumption). Since high MEE is associated with a better prognosis in HFrEF, manipulating substrate uptake could be a new treatment modality in heart failure patients.\n\nRecently, it was shown that the human myocardium increases 3-hydroxybutyrate (3-OHB) metabolism during development of HFrEF. These changes may be beneficial as 3-OHB could increase myocardial efficiency and lower oxidative stress by scavenging free radicals. However, until now this has not been investigated in clinical trials, and the effect of 3-OHB on cardiac function, oxygen consumption and perfusion remains undetermined in HFrEF patients.\n\nIn the present study the investigators will evaluate whether elevated circulating 3-OHB affect myocardial oxygen consumption, MEE and perfusion in healthy subjects and patients with HFrEF, and whether 3-OHB affect hemodynamics and contractile function.\n\n10 healthy test subjects and 20 HFrEF patients will be subjected to placebo and 3-OHB infusion in a randomized cross-over design. Acetate-PET, echocardiography and right sided heart catheterization will be applied.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* For participants with heart failure:\n* Symptoms of Heart failure NYHA 2-3\n* LVEF\\<40%\n\nFor all participants:\n\n* Negative HCG for women in the pregnant age\n\nExclusion Criteria:\n\n* Significant cardiac valve disease\n* Signs or history of major myocardial infarction (STEMI) within 3 months\n* Other disease or treatment making subject unsuitable for study participation\n* Treatment for diabetes or HbA1c level \\>7%'}, 'identificationModule': {'nctId': 'NCT03073356', 'briefTitle': 'Ketones in Heart Failure - Effects on Cardiac Efficiency', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Effects of Ketones on Cardiac Function and Oxygen Consumption in Heart Failure Patients With Reduced Ejection Fraction and Healthy Test Subjects', 'orgStudyIdInfo': {'id': '1-10-72-316-16'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Control - Healthy test subjects', 'description': 'Age matched subjects without symptoms of heart failure or ischemic heart disease N=10', 'interventionNames': ['Biological: Infusion of 3-OHB', 'Biological: Infusion of placebo']}, {'type': 'EXPERIMENTAL', 'label': 'HFrEF - Heart failure patients investigated by PET', 'description': 'Patients with heart failure (HFrEF) N=12', 'interventionNames': ['Biological: Infusion of 3-OHB', 'Biological: Infusion of placebo']}, {'type': 'EXPERIMENTAL', 'label': 'HFrEF - Right heart catheterization', 'description': 'Patients with heart failure (HFrEF) N=12', 'interventionNames': ['Biological: Infusion of 3-OHB', 'Biological: Infusion of placebo']}, {'type': 'EXPERIMENTAL', 'label': 'HFrEF - Right heart catheterization study 2', 'description': 'Dose finding study (increasing dosage of 3-OHB)', 'interventionNames': ['Biological: Infusion of 3-OHB', 'Biological: Infusion of placebo']}], 'interventions': [{'name': 'Infusion of 3-OHB', 'type': 'BIOLOGICAL', 'otherNames': ['Na-3-OHB'], 'description': 'Increase in 3-OHB levels', 'armGroupLabels': ['Control - Healthy test subjects', 'HFrEF - Heart failure patients investigated by PET', 'HFrEF - Right heart catheterization', 'HFrEF - Right heart catheterization study 2']}, {'name': 'Infusion of placebo', 'type': 'BIOLOGICAL', 'otherNames': ['NaCl'], 'description': 'NaCl', 'armGroupLabels': ['Control - Healthy test subjects', 'HFrEF - Heart failure patients investigated by PET', 'HFrEF - Right heart catheterization', 'HFrEF - Right heart catheterization study 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8200', 'city': 'Aarhus', 'state': 'Central Jutland', 'country': 'Denmark', 'facility': 'Dept. of cardiology, Aarhus university hospital Skejby', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'overallOfficials': [{'name': 'Roni R Nielsen, MD PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept. of Cardiology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}