Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2025-12-25 @ 5:26 PM
Study NCT ID:
NCT06350903
Status:
COMPLETED
Last Update Posted:
2025-09-29
First Post:
2024-03-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Suppression With Empagliflozin as an Alternative To High-Fat Low-Carbohydrate Diet for Myocardial F-fluorodeoxyglucose Positron Emission Tomography (FDG-PET) Imaging
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C570240', 'term': 'empagliflozin'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-23', 'studyFirstSubmitDate': '2024-03-18', 'studyFirstSubmitQcDate': '2024-04-03', 'lastUpdatePostDateStruct': {'date': '2025-09-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Levels of serum Beta-hydroxybutyrate (BHB) mmol/L', 'timeFrame': '1 day', 'description': 'Average differences in serum levels of BHB measured following a fast and administration of empagliflozin versus following a fast preceded by a HFLC diet'}], 'secondaryOutcomes': [{'measure': 'Proportions of serum Beta-hydroxybutyrate (BHB) >0.5 mmol/L', 'timeFrame': '1 day', 'description': 'Proportion of participants with serum BHB \\>0.5 mmol/L following a fast and administration of empagliflozin versus following a fast preceded by a HFLC diet.'}, {'measure': 'Proportions of glycemia levels (mmol/L) <3.5 mmol/L', 'timeFrame': '1 day', 'description': 'Proportion of participants with glycemia \\<3.5 mmol/L following a fast and administration of empagliflozin versus following a fast preceded by a HFLC diet.'}, {'measure': 'Acceptability and tolerance of each protocol, as reported by patients by a dedicated survey.', 'timeFrame': 'Through study completion, up to 3 months.', 'description': 'Proportion of participants who preferred the empagliflozin to the HFLC diet as assessed by a dedicated survey.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myocardial Suppression']}, 'descriptionModule': {'briefSummary': 'The overall objective of this study is to assess if the empagliflozin has the potential to substitute the high fat low carb (HFLC) diet for the preparation of cardiovascular FDG-PET studies.', 'detailedDescription': 'The overall objective of this study is to assess if the SGLT2 inhibitor empagliflozin has the potential to substitute the high fat low carb (HFLC) diet for the preparation of cardiovascular FDG-PET studies. This study will evaluate if an acute administration of empagliflozin (tablets of 10 and/or 25 mg) combined with fasting can sufficiently increase the BHB levels, a proxy of myocardial FDG uptake.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged 18 to 70 years\n2. Ability to follow the HFLC diet\n3. Ability to provide informed consent\n\nExclusion Criteria:\n\n1. Treated with SGLT2 inhibitors\n2. History of hypersensitivity or allergy to empagliflozin\n3. Hypotension with blood pressure \\<100/65 mmHg\n4. Strict vegan\n5. Pregnancy\n6. Breastfeeding\n7. Type I or type II diabetes\n8. Renal failure with Estimated Glomerular Filtration Rate (eGFR) \\<60 mL/min/1.72m2\n9. Receiving steroids\n10. History of diabetic ketoacidosis (DKA)\n11. History of hypoglycemia\n12. Any condition that, in the opinion of the investigator, could compromise the participation in the study'}, 'identificationModule': {'nctId': 'NCT06350903', 'acronym': 'SWEET-HEART', 'briefTitle': 'Suppression With Empagliflozin as an Alternative To High-Fat Low-Carbohydrate Diet for Myocardial F-fluorodeoxyglucose Positron Emission Tomography (FDG-PET) Imaging', 'organization': {'class': 'OTHER', 'fullName': 'Montreal Heart Institute'}, 'officialTitle': 'Suppression With Empagliflozin as an Alternative To High-Fat Low-Carbohydrate Diet for Myocardial FDG-PET Imaging', 'orgStudyIdInfo': {'id': 'ICM 2024-3356'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Fast + High-fat low-carbohydrate diet', 'type': 'OTHER', 'description': 'Participants will be instructed to follow a strict HFLC diet starting on the morning of the day before the visit and to fast for 14 hours, starting at 7pm the day before the visit. Participants will be allowed to drink water and take their medications.'}, {'name': 'Fast + Empagliflozin', 'type': 'COMBINATION_PRODUCT', 'description': 'Participants will be instructed to fast for 14 hours, starting at 7pm the day before the visit. Participants will be allowed to drink water and take their medications. Participants will also be instructed to take an oral dose of 50 mg of empagliflozin at 7am the morning before the experimental visit and on the day of the experimental visit.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H1T1C8', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Montreal Heart Institute', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Matthieu Pelletier-Galarneau, MD MSc', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Chief, division of nuclear medicine at Institut de cardiologie de Montreal', 'investigatorFullName': 'Matthieu Pelletier-Galarneau, MD MSc', 'investigatorAffiliation': 'Montreal Heart Institute'}}}}