Ignite Creation Date:
2025-12-24 @ 4:51 PM
Ignite Modification Date:
2026-04-17 @ 7:34 AM
Study NCT ID:
NCT05161650
Status:
COMPLETED
Last Update Posted:
2023-11-30
First Post:
2021-12-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hemodynamic Effects of Chronic Ketosis.
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-29', 'studyFirstSubmitDate': '2021-12-03', 'studyFirstSubmitQcDate': '2021-12-03', 'lastUpdatePostDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Resting cardiac output (L/min)', 'timeFrame': '14 days of dietary supplement', 'description': 'Measured with right heart catheterization'}], 'secondaryOutcomes': [{'measure': 'Resting pulmonary capillary wedge pressure (PCWP)', 'timeFrame': '14 days of dietary supplement', 'description': 'Measured with right heart catheterization'}, {'measure': 'Peak exercise pulmonary capillary wedge pressure (PCWP)', 'timeFrame': '14 days of dietary supplement', 'description': 'Measured with right heart catheterization'}, {'measure': 'Peak exercise cardiac output (L/min)', 'timeFrame': '14 days of dietary supplement', 'description': 'Measured with right heart catheterization'}, {'measure': 'Exercise capacity (METs)', 'timeFrame': '14 days of dietary supplement', 'description': 'Cardiopulmonary exercise test'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Failure']}, 'referencesModule': {'references': [{'pmid': '38533643', 'type': 'DERIVED', 'citation': 'Berg-Hansen K, Gopalasingam N, Christensen KH, Ladefoged B, Andersen MJ, Poulsen SH, Borlaug BA, Nielsen R, Moller N, Wiggers H. Cardiovascular Effects of Oral Ketone Ester Treatment in Patients With Heart Failure With Reduced Ejection Fraction: A Randomized, Controlled, Double-Blind Trial. Circulation. 2024 May 7;149(19):1474-1489. doi: 10.1161/CIRCULATIONAHA.123.067971. Epub 2024 Mar 27.'}]}, 'descriptionModule': {'briefSummary': 'Heart Failure (HF) is a major public health issue because the disease affects 1-2% of the Western population and the lifetime risk of HF is 20%. Despite major improvements in the management and care of patients with HF, the 1-year mortality in patients with HF is 13% and \\>50% of HF patients are admitted during a 2.5 year period. Furthermore, patients with HF have markedly decreased physical capacity and quality of life. Thus, there is a need for new treatment modalities in this group of patients.\n\nWe have shown, using positron emission tomography, that ketone body infusion reduces myocardial glucose uptake and increases myocardial blood flow in healthy subjects. Data from another study conducted by our group show a 40% increase in cardiac output during infusion of 3-OHB in patients with HF and reduced left ventricular ejection fraction (HFrEF).\n\nPresently there are no data on the clinical cardiovascular effects of long-term oral ketone-supplementation in patients with chronic HF.\n\nIn this study we aim to investigate the effect of 14 days modulation of circulating ketone body levels on cardiac function and exercise capacity in patients with HFrEF.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic heart failure with NYHA II-III\n* Left ventricular ejection fraction ≤40%\n* Negative urine-HCG for women with childbearing potential\n\nExclusion Criteria:\n\n* Known diabetes or HbA1c ≥48 mmol/mol\n* Significant cardiac valve disease\n* Severe stable angina pectoris\n* Age \\<18 years'}, 'identificationModule': {'nctId': 'NCT05161650', 'acronym': 'KETO-CHF', 'briefTitle': 'Hemodynamic Effects of Chronic Ketosis.', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Modulation of Circulating Levels of the Ketone Body 3-hydroxybutyrate in Patients With Chronic Heart Failure: Cardiovascular Effects', 'orgStudyIdInfo': {'id': 'KETO-CHF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ketone monoester (3-OHB)', 'interventionNames': ['Dietary Supplement: Ketone monoester (3-OHB)']}, {'type': 'EXPERIMENTAL', 'label': 'Isocaloric placebo', 'interventionNames': ['Dietary Supplement: Placebo drink']}], 'interventions': [{'name': 'Ketone monoester (3-OHB)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Commercially available ketone supplement', 'armGroupLabels': ['Ketone monoester (3-OHB)']}, {'name': 'Placebo drink', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Isocaloric placebo', 'armGroupLabels': ['Isocaloric placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DK-8200', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Kristoffer Berg-Hansen', 'investigatorAffiliation': 'University of Aarhus'}}}}