Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-26 @ 2:33 AM
Study NCT ID:
NCT06171802
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-20
First Post:
2023-11-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
EMPagliflozin After Aortic Valve Replacement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001024', 'term': 'Aortic Valve Stenosis'}], 'ancestors': [{'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C570240', 'term': 'empagliflozin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double-blinded trial'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized placebo-controlled'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 205}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-02-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2023-11-23', 'studyFirstSubmitQcDate': '2023-12-06', 'lastUpdatePostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in left ventricular mass indexed to body surface area', 'timeFrame': '6 months from discharge post-Aortic Valve Replacement', 'description': 'Change in left ventricular mass indexed to body surface area (measured by CT) from pre-Aortic Valve Replacement to 6-months post-Aortic Valve Replacement'}], 'secondaryOutcomes': [{'measure': 'LVESVi', 'timeFrame': '6-months from discharge post-aortic valve replacement', 'description': 'Left ventricular end-systolic volume indexed to body surface (LVESVi) (measured by CT)'}, {'measure': 'LV GLS (echo)', 'timeFrame': '3- and 6-months from discharge', 'description': 'Left ventricular global longitudinal strain (LV GLS) (measured by echocardiography)'}, {'measure': 'N-terminal pro B-type natriuretic peptide (NT-proBNP) change', 'timeFrame': '3- and 6-months from discharge', 'description': 'NT-proBNP change from baseline to 6 months'}, {'measure': 'Death and readmission for any non-planned cause', 'timeFrame': '6 months from discharge date (after aortic valve replacement)', 'description': 'A composite outcome of death and readmission for any non-planned cause'}, {'measure': 'Death', 'timeFrame': '6 months from discharge date (after aortic valve replacement)', 'description': 'Death during follow-up, from discharge to 6-months after discharge'}, {'measure': 'Readmission for any cause', 'timeFrame': '6 months from discharge date (after aortic valve replacement)', 'description': 'Readmission for any cause to any hospital after discharge'}, {'measure': 'Admission for heart failure', 'timeFrame': '6 months from discharge date (after aortic valve replacement)', 'description': 'Admission for heart failure to any hospital'}, {'measure': 'Kansas City Cardiomyopathy Questionaire (KCCQ)', 'timeFrame': '6 months from discharge date (after aortic valve replacement)', 'description': 'Change in symptom score (KCCQ) at 6-months. KCCQ scores are scaled from 0 to 100, where scores represent health status as follows: 0-24: very poor to poor; 25-49: poor to fair; 50-74: fair to good; and 75-100: good to excellent.\n\nIn this study a change of 5 points is considered a meaningful change.'}, {'measure': 'Quality of Life (QoL) - The Minnesota Living with Heart Failure Questionnaire (MLHFQ)', 'timeFrame': '6 months from discharge date (after aortic valve replacement)', 'description': "Quality of life assessment at baseline and 6 months after discharge post-AVR using the Minnesota Living with Heart Failure Questionnaire (MLHFQ).\n\nMLHFQ consist of 21 questions. The response format ranges from 0 (none or not applicable), to 1 (very little) to 5 (very much). The sum of responses ranges from 0 to 105. The score increases with adverse impact of the disease on the respondent's life."}, {'measure': 'New York Heart Association (NYHA) Functional Classification', 'timeFrame': '3- and 6-months from discharge date (after aortic valve replacement)', 'description': 'Change in symptom score at 6 months (NYHA classification).\n\nThe NYHA classification places patients in one of four categories based on limitations of physical activity. Class I: No limitation of physical activity; Class II: Slight limitation of physical activity; Class III: Marked limitation of physical activity; Class IV: Symptoms of heart failure at rest.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Aortic Valve Stenosis', 'Aortic Valve Replacement', 'Transcatheter Aortic Valve Implantation', 'Aortic Valve', 'Sodium-Glucose Cotransporter-2 inhibitor', 'SGLT2i', 'Empagliflozin'], 'conditions': ['Aortic Valve Stenosis']}, 'descriptionModule': {'briefSummary': 'The study is a randomized, placebo-controlled, and double-blinded trial in patients with aortic stenosis (AS) undergoing aortic valve replacement (AVR). After AVR, patients will be randomized 1:1 to empagliflozin (SGLT2i) or placebo to investigate whether empagliflozin is superior to placebo in reducing left ventricular mass and improve symptoms to 6 months.', 'detailedDescription': 'In this randomized, placebo-controlled, and double-blinded trial we investigate whether empagliflozin (SGLT2i) is superior to placebo in reducing left ventricular mass and improve symptoms.\n\nAll patients with AS who are referred to Rigshospitalet for AVR (both surgical and transcatheter approaches) will be screened for in- and exclusion criteria in the medical record based on the Danish Health Act §46 by the PI, co-PI, or a delegated study nurse. If the patient fulfills the inclusion criteria and none of the exclusions criteria, the patient is invited to participate in the study.\n\nIncluded patients will be randomized 1:1 in blocks of 2, 4, and 6 patients to either Empagliflozin 10 mg daily or placebo. Point of randomization will be in the hospital when the patients has undergone AVR.\n\nThe total treatment period is 6 months with either 10 mg Empagliflozin or placebo. The trial participants will receive conventional treatment, which will be carried out irrespective of the inclusion in the trial in accordance with national guidelines. Routine clinical check-ups irrespective of the trial setup will be performed at 3 months after discharge, and study-outcomes will be assessed at discharge, 3 months, and 6 months (eg. echocardiography). Blood samples (including N-Terminal-proBNP, renal function and electrolytes, hemoglobin and HbA1c) will be part of such routine visits as well as a standardized symptom-scoring tool (KCCQ and NYHA classification). Compliance will be evaluated at 1-, 3- and 6-months. The assessment for 1-month will be per telephone and the assessment at 3- and 6-months will be at the routine clinical check-ups in the outpatient clinic.\n\nThe CT scan performed in the planning of the procedure will be used for the baseline assessment (before AVR). An identical exam (CT scan) will be performed at 6 months to assess change in LV mass.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSevere symptomatic aortic stenosis AND Surgical or transcatheter aortic valve replacement within 14 days\n\nExclusion Criteria:\n\n* Prior treatment with a SGLT2i\n* Left ventricular ejection fraction \\< 45%\n* Estimated Glomerular Filtration Rate (eGFR) \\< 30 mL/min\n* Hypersensitivity to empagliflozin or placebo tablet\n* Type I Diabetes\n* Patients who do not understand Danish or English\n* Women who are pregnant or are nursing or plan to become pregnant during trial'}, 'identificationModule': {'nctId': 'NCT06171802', 'acronym': 'EMPAVR', 'briefTitle': 'EMPagliflozin After Aortic Valve Replacement', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'EMPagliflozin After Aortic Valve Replacement - The EMPAVR Study - A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '2023-504731-40-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Empagliflozin', 'description': 'Empagliflozin 1 capsule of 10 mg, once daily for six months.', 'interventionNames': ['Drug: Empagliflozin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '1 capsule of placebo, once daily for six months', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Empagliflozin', 'type': 'DRUG', 'otherNames': ['Jardiance'], 'description': '10 mg empagliflozin daily for six months', 'armGroupLabels': ['Empagliflozin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo capsule once daily for six months', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'University Hospital of Copenhagen, Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Emil L. Fosbøl, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of Copenhagen - Rigshospitalet'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, MD, PhD', 'investigatorFullName': 'Emil Loldrup Fosbol', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}