Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-28 @ 6:40 PM
Study NCT ID:
NCT05084235
Status:
COMPLETED
Last Update Posted:
2025-01-29
First Post:
2021-09-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Cardiac Effects of Empagliflozin in Patients With High Risk of Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C570240', 'term': 'empagliflozin'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-01-23', 'size': 908108, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-01-24T16:45', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 191}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-01-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-26', 'studyFirstSubmitDate': '2021-09-03', 'studyFirstSubmitQcDate': '2021-10-06', 'lastUpdatePostDateStruct': {'date': '2025-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Quality-of-life scores', 'timeFrame': '180 days', 'description': 'Between-group difference in the change of self-reported quality of life assessed by the 36-item short form health survey (SF-36 questionnaire). The SF-36 targets eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Each item is scored on a scale from 0 to 100, with a higher score representing a more favorable health state. An average score is calculated for each health concept.'}, {'measure': 'Blood pressure', 'timeFrame': '180 days', 'description': 'Between-group difference in the change of systolic and diastolic blood pressure assessed by ambulatory blood pressure measurement'}, {'measure': 'Wall stress', 'timeFrame': '180 days', 'description': 'Between-group difference in the change of estimated end-systolic wall stress (ESWS). ESWS will be calculated from results of multimodality imaging combining MRI and echocardiography by using a formula incorporating MRI LV end-systolic diameter and wall thickness as well as echocardiographic mean and arterial blood pressure as proposed by Reichek et al. based on the Law of Laplace. (please see references Reichek et al and Carter-Storch et al. in the reference list)'}, {'measure': 'Left atrium size', 'timeFrame': '180 days', 'description': 'Between-group difference in the change of left atrial maximal and minimal size measured by cardiac magnetic resonance image'}, {'measure': 'Global strain', 'timeFrame': '180 days', 'description': 'Between-group difference in the change of global strain assessed by cardiac magnetic resonance image'}, {'measure': 'Growth differentiation factor 15', 'timeFrame': '180 days', 'description': 'Between-group difference in the change of the biomarker growth differentiation factor 15 (pg/ml)'}, {'measure': 'Cardiac fibrosis', 'timeFrame': '180 days', 'description': 'Between-group difference in the change of cardiac fibrosis assessed by cardiac magnetic resonance image'}, {'measure': 'Left atrium function', 'timeFrame': '180', 'description': 'Between-group difference in the change of left atrial emptying fraction and left atrium ejection fraction assessed by cardiac magnetic resonance image'}, {'measure': 'Biomarkers of heart disease', 'timeFrame': '180 days', 'description': 'Between-group difference in the change of biomarkers of heart disease, including atrial natriuretic peptide (ANP), brain (B-type) natriuretic peptide (BNP), and N-terminal pro-hormone BNP (NT-proBNP). All measured as pmol/L.'}], 'primaryOutcomes': [{'measure': 'Left ventricular mass index', 'timeFrame': '180 days', 'description': 'Between-group difference in the change of left ventricular mass index (LVMI) assessed by cardiac magnetic resonance image'}, {'measure': 'Maximal oxygen consumption', 'timeFrame': '180 days', 'description': 'Between-group difference in the change of maximal oxygen consumption (peak VO2) assessed by cardiopulmonary exercise test'}], 'secondaryOutcomes': [{'measure': 'Left ventricular volume', 'timeFrame': '180 days', 'description': 'Between-group difference in the change of left ventricular end-diastolic volume index (LVEDVI) and left ventricular end-systolic volume index (LVESVI) assessed by cardiac magnetic resonance image'}, {'measure': 'Left ventricular function', 'timeFrame': '180 days', 'description': 'Between-group difference in the change of first phase ejection fraction and left ventricular ejection fraction (LVEF) assessed by cardiac magnetic resonance image'}, {'measure': 'Daily activity level', 'timeFrame': '180 days', 'description': 'Between-group difference in the change of daily activity level assessed by accelerometer'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Failure', 'Obesity']}, 'referencesModule': {'references': [{'pmid': '7053293', 'type': 'BACKGROUND', 'citation': 'Reichek N, Wilson J, St John Sutton M, Plappert TA, Goldberg S, Hirshfeld JW. Noninvasive determination of left ventricular end-systolic stress: validation of the method and initial application. Circulation. 1982 Jan;65(1):99-108. doi: 10.1161/01.cir.65.1.99. No abstract available.'}, {'pmid': '31168387', 'type': 'BACKGROUND', 'citation': 'Carter-Storch R, Moller JE, Christensen NL, Rasmussen LM, Pecini R, Sondergard E, Videbaek LM, Dahl JS. End-systolic wall stress in aortic stenosis: comparing symptomatic and asymptomatic patients. Open Heart. 2019 Apr 9;6(1):e001021. doi: 10.1136/openhrt-2019-001021. eCollection 2019.'}, {'pmid': '38365073', 'type': 'DERIVED', 'citation': 'Andersen CF, Larsen JH, Jensen J, Omar M, Nouhravesh N, Kistorp C, Tuxen C, Gustafsson F, Knop FK, Forman JL, Davidovski FS, Jensen LT, Hojlund K, Kober L, Antonsen L, Poulsen MK, Schou M, Moller JE. Empagliflozin to elderly and obese patients with increased risk of developing heart failure: Study protocol for the Empire Prevent trial program. Am Heart J. 2024 May;271:84-96. doi: 10.1016/j.ahj.2024.02.005. Epub 2024 Feb 15.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this trial is to assess the effect of Empagliflozin on cardiac mass, volumes, cardiac biomarkers, metabolism, daily activity level, health-related quality of life in patients in elderly and obese patients with increased risk of developing heart failure. The primary hypotheses are that 180 days of treatment with Empagliflozin 10 mg a day will: 1) reduce left ventricular mass index, and 2) increase peak VO2 (maximal oxygen consumption) compared with placebo.', 'detailedDescription': 'The Empire Prevent: Cardiac is a part of the Empire Prevent Trial Program, which also comprises the Empire Prevent: Metabolic'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '84 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body mass index \\>28kg/m2\n* Age 60-84 years\n* Established risk factor for developing heart failure, defined as at least one of the following:\n* hypertension\n* ischemic heart disease\n* stroke/transient cerebral ischemia\n* chronic kidney disease (eGFR 30-45ml/min/1.73m2)\n\nExclusion Criteria:\n\n* Diabetes mellitus type 1 or 2 (no medical history, no antidiabetic treatment)\n* Heart failure with reduced ejection fraction (LVEF \\<40%)\n* Inability to perform exercise test\n* Dementia\n* Severe non-compliance\n* Substance abuse\n* Severe chronic obstructive pulmonary disease (FEV1\\<50% expected value)\n* Permanent atrial fibrillation\n* GFR \\<30 ml/min/1,73m2\n* Severe peripheral artery disease\n* Cancer treatment within one year beside prostate cancer and basal cell carcinoma\n* Severe aortic or mitral valve disease\n* Pregnancy or breastfeeding\n* Acute hospital admission within 30 days\n* Participation in other pharmacological study'}, 'identificationModule': {'nctId': 'NCT05084235', 'briefTitle': 'The Cardiac Effects of Empagliflozin in Patients With High Risk of Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'Odense University Hospital'}, 'officialTitle': 'Empagliflozin to Elderly and Obese Patients With Cardiovascular Disease (Empire Prevent: Cardiac): A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'S-20210028-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Empaglifloxin', 'interventionNames': ['Drug: Empagliflozin 10 MG']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Empagliflozin 10 MG', 'type': 'DRUG', 'description': 'Patients are randomized 1:1 to receive either Empagliflozin or matching placebo for 180 days', 'armGroupLabels': ['Empaglifloxin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo matches the active drug in appearance, odor and labelling', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2730', 'city': 'Herlev', 'country': 'Denmark', 'facility': 'Herlev Hospital', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}, {'zip': '5000', 'city': 'Odense', 'country': 'Denmark', 'facility': 'Odense University Hospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}], 'overallOfficials': [{'name': 'Jacob Eifer Møller, MD, PhD,', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Odense University Hospital'}, {'name': 'Morten Schou, MD, PhD, DmSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Herlev-Gentofte Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jacob Moller', 'class': 'OTHER'}, 'collaborators': [{'name': 'Danish Heart Foundation', 'class': 'OTHER'}, {'name': 'Herlev and Gentofte Hospital', 'class': 'OTHER'}, {'name': 'University Hospital Bispebjerg and Frederiksberg', 'class': 'OTHER'}, {'name': 'Hillerod Hospital, Denmark', 'class': 'OTHER'}, {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor, MD, PhD', 'investigatorFullName': 'Jacob Moller', 'investigatorAffiliation': 'Odense University Hospital'}}}}