Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2025-12-25 @ 8:11 PM
Study NCT ID:
NCT05236335
Status:
COMPLETED
Last Update Posted:
2023-10-10
First Post:
2021-12-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Modulation of Circulating Levels of the Ketone Body 3-hydroxybutyrate in Patients With Type 2 Diabetes and Heart Failure With Preserved Ejection Fraction: Cardiovascular Effects.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D007662', 'term': 'Ketosis'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D000138', 'term': 'Acidosis'}, {'id': 'D000137', 'term': 'Acid-Base Imbalance'}]}, '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']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-06', 'studyFirstSubmitDate': '2021-12-02', 'studyFirstSubmitQcDate': '2022-02-01', 'lastUpdatePostDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiac Output (L/min)', 'timeFrame': '14 days ketone ester treatment', 'description': 'Right heart catheterization'}], 'secondaryOutcomes': [{'measure': 'Pulmonal wedge capillary Pressure (PCWP)', 'timeFrame': '14 days ketone ester treatment', 'description': 'Right heart catheterization'}, {'measure': 'Exercise capacity (METs)', 'timeFrame': '14 days ketone ester treatment', 'description': 'Cardiopulmonary exercise test'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Failure With Preserved Ejection Fraction', 'Diabetes Mellitus, Type 2', 'Ketonemia']}, 'referencesModule': {'references': [{'pmid': '39162035', 'type': 'DERIVED', 'citation': 'Gopalasingam N, Berg-Hansen K, Christensen KH, Ladefoged BT, Poulsen SH, Andersen MJ, Borlaug BA, Nielsen R, Moller N, Wiggers H. Randomized Crossover Trial of 2-Week Ketone Ester Treatment in Patients With Type 2 Diabetes and Heart Failure With Preserved Ejection Fraction. Circulation. 2024 Nov 12;150(20):1570-1583. doi: 10.1161/CIRCULATIONAHA.124.069732. Epub 2024 Aug 20.'}]}, 'descriptionModule': {'briefSummary': 'Heart failure (HF) is among the most common causes of death in patients with type 2 diabetes (T2D). Ketones, 3-hydroxybutyrate (3-OHB), have shown to have beneficial hemodynamics effect in patients with hearth failure with reduced ejection fraction. However, this have never been investigated in patients with heart failure with preserved ejection fraction (HFpEF).\n\nIn this study we would like to investigate the effect of 14 days modulation of circulating ketone body levels on cardiac function and exercise capacity in patients with HFpEF and T2D.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Type 2 diabetes\n* LVEF \\> 40 %\n* a clinical diagnosis of HFpEF and/or left ventricular hypertrophy (posterior wall thickness \\> 12 mm) and/or previous myocardial infarction\n* age ≥ 18 years old,\n* one of the following criteria (a-d) should be fulfilled:\n\n 1. Echocardiographic signs of diastolic dysfunction E/e' \\> 8\n 2. Septal e ́\\< 7 cm/s and/or lateral e ́ \\< 10 cm/s\n 3. Left atrium volume index ≥34 mL/m2 and/or left atrial diameter \\> 4 cm\n 4. NT-proBNP \\> 125 pg/ml.\n\nExclusion Criteria:\n\n* Insulin treatment, inability to give informed consent"}, 'identificationModule': {'nctId': 'NCT05236335', 'acronym': 'KETO-HFpEF', 'briefTitle': 'Modulation of Circulating Levels of the Ketone Body 3-hydroxybutyrate in Patients With Type 2 Diabetes and Heart Failure With Preserved Ejection Fraction: Cardiovascular Effects.', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Modulation of Circulating Levels of the Ketone Body 3-hydroxybutyrate in Patients With Type 2 Diabetes and Heart Failure With Preserved Ejection Fraction: Cardiovascular Effects.', 'orgStudyIdInfo': {'id': '0059'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ketone ester', 'interventionNames': ['Dietary Supplement: Ketone ester']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Dietary Supplement: Placebo drink']}], 'interventions': [{'name': 'Ketone ester', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Commercially available ketone supplement', 'armGroupLabels': ['Ketone ester']}, {'name': 'Placebo drink', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Isocaloric placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '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': 'SPONSOR'}}}}