Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2025-12-25 @ 6:58 PM
Study NCT ID:
NCT03411304
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-12-09
First Post:
2017-08-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Aortic Stenosis: Determinants and Prognostic Value of Preoperative Left Ventricular Remodeling After Valvular Replacement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001024', 'term': 'Aortic Valve Stenosis'}, {'id': 'D020257', 'term': 'Ventricular Remodeling'}], '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'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 440}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-12-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-04', 'studyFirstSubmitDate': '2017-08-21', 'studyFirstSubmitQcDate': '2018-01-24', 'lastUpdatePostDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of clinical events according to left ventricular remodeling', 'timeFrame': 'Year 1', 'description': 'Echocardiography and MRI'}, {'measure': 'Occurrence of clinical events according to left ventricular remodeling', 'timeFrame': 'Year 2', 'description': 'Echocardiography and MRI'}, {'measure': 'Occurrence of clinical events according to left ventricular remodeling', 'timeFrame': 'Year 3', 'description': 'Echocardiography and MRI'}, {'measure': 'Occurrence of clinical events according to left ventricular remodeling', 'timeFrame': 'Year 4', 'description': 'Echocardiography and MRI'}], 'secondaryOutcomes': [{'measure': 'Evolution of left ventricular remodeling after aortic valvular replacement', 'timeFrame': 'Year 1', 'description': 'Echocardiography and MRI'}, {'measure': 'Prognostic value of persistence and type of left ventricular remodeling', 'timeFrame': 'Year 1', 'description': 'Echocardiography and MRI Occurence of clinical events'}, {'measure': 'Prognostic value of fibrosis', 'timeFrame': 'Year 1', 'description': 'Echocardiography and MRI Occurence of clinical events'}, {'measure': 'Prognostic value of biomarkers', 'timeFrame': 'Year 1'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Aortic valvular replacement', 'Aortic stenosis', 'Left ventricular remodeling', 'biomarkers'], 'conditions': ['Aortic Valve Stenosis']}, 'descriptionModule': {'briefSummary': 'Aortic stenosis (AS) is the most frequent valvulopathy in Western countries. The prevalence of AS is constantly increasing due to the aging of the population. Although significant progress has been made in understanding the pathophysiological mechanisms underlying the onset and progression of AS, there is no medical treatment to slow or prevent its progression. The only treatment available is Aortic Valve Replacement (AVR) performed by surgery or by catheterization (TAVI).\n\nAS is associated with an increase of post-load which leads the left ventricular myocardium to hypertrophy. Associated with hypertrophy, myocardial fibrosis will gradually develop. Despite interesting data, many unknowns persist and remain to be identified.\n\nThe aim of the study is to characterize prospectively the left ventricular remodeling and assess its changes after AVR and within 1 year in 500 patients using clinical, biological, echocardiographic and MRI parameters.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with at least moderate aortic stenosis and in whom an intervention is programmed or indicated', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aortic stenosis\n* Indication of Aortic Valve Replacement (Surgery or TAVI)\n\nExclusion Criteria:\n\n* Rheumatismal or congenital aortic stenosis\n* Aortic insufficiency (grade \\>= 2/4)\n* Associated valvulopathy (grade \\>= 2/4)\n* Myocardial infarction antecedent\n* Severe renal failure\n* Cardiac surgery (Aorta abdominal) antecedent\n* Complex congenital cardiopathy'}, 'identificationModule': {'nctId': 'NCT03411304', 'briefTitle': 'Aortic Stenosis: Determinants and Prognostic Value of Preoperative Left Ventricular Remodeling After Valvular Replacement', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Rouen'}, 'officialTitle': 'Aortic Stenosis: Determinants and Prognostic Value of Preoperative Left Ventricular Remodeling After Valvular Replacement (AS-INTERVENTION)', 'orgStudyIdInfo': {'id': '2017/080/HP'}}, 'contactsLocationsModule': {'locations': [{'city': 'Rouen', 'country': 'France', 'facility': 'UH Rouen', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}], 'overallOfficials': [{'name': 'Helene Eltchaninoff, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Rouen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Rouen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}