Ignite Creation Date:
2025-12-24 @ 2:59 PM
Ignite Modification Date:
2026-02-28 @ 1:17 PM
Study NCT ID:
NCT04820959
Status:
COMPLETED
Last Update Posted:
2024-02-28
First Post:
2021-03-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of New Therapeutic Targets to Prevent Collagen Accumulation During Cardiac Fibrosis: Procollagen C-proteinase Enhancers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006349', 'term': 'Heart Valve Diseases'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001706', 'term': 'Biopsy'}, {'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D011677', 'term': 'Punctures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2022-07-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-26', 'studyFirstSubmitDate': '2021-03-25', 'studyFirstSubmitQcDate': '2021-03-25', 'lastUpdatePostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Myocardial fibrosis rate', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Measurement of the level of myocardial fibrosis in myocardial tissue.'}, {'measure': 'Rate of PCPE-1/2', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Measurement of PCPE-1/2 rate in myocardial tissue.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Valvulopathy', 'Heart Surgery', 'Procollagen C-Proteinase Enhancers']}, 'descriptionModule': {'briefSummary': 'Heart failure is characterized by cardiac fibrosis linked to extracellular collagen deposits. Collagens are synthesized as soluble precursors, procollagens, which must undergo proteolytic maturation to assemble into fibres. This step is under the control of two extracellular proteins, procollagen C-proteinase enhancer 1 and 2 (PCPE-1 and -2). The mechanism of action of these highly effective and specific activators was recently elucidated by one of our partners. Preliminary results, as well as data from the literature, indicate a strong correlation between the expression rates of PCPEs and cardiac fibrosis. The aim of this study is to validate in humans, by analysis of endomyocardial tissue biopsies, the hypothesis that PCPEs contribute to the anarchic accumulation of collagen during cardiac fibrosis and to evaluate the interest of developing new diagnostic and therapeutic strategies for cardiac fibrosis using PCPE agonists.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Person who has given written consent\n* Patient aged 18 to 85 for men and 60 to 85 for women\n* Patient requiring cardiac surgery for aortic valve replacement or aortic plastic surgery or aortic plasty or ascending aorta replacement more or less associated with aortic valve surgery\n\nExclusion Criteria:\n\n* Person not affiliated or not benefiting from national health insurance\n* Person subject to a measure of legal protection (curatorship, guardianship)\n* Person deprived of liberty, by judicial or administrative decision\n* Major incapable or incapable of giving consent\n* Minor\n* Pregnant or breastfeeding woman\n* Emergency Surgery\n* Acute Infectious Endocarditis'}, 'identificationModule': {'nctId': 'NCT04820959', 'acronym': 'CARDIACTIV', 'briefTitle': 'Validation of New Therapeutic Targets to Prevent Collagen Accumulation During Cardiac Fibrosis: Procollagen C-proteinase Enhancers', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Dijon'}, 'officialTitle': 'Validation of New Therapeutic Targets to Prevent Collagen Accumulation During Cardiac Fibrosis: Procollagen C-proteinase Enhancers', 'orgStudyIdInfo': {'id': 'BOUCHOT ANR 2017'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Biopsies', 'type': 'BIOLOGICAL', 'description': 'Three endomyocardial intraoperative biopsies were performed on the left ventricle.\n\nResection of the left atrium in the event of atrial fibrillation.'}, {'name': 'Blood sampling', 'type': 'BIOLOGICAL', 'description': 'Pre-operative blood sampling'}]}, 'contactsLocationsModule': {'locations': [{'zip': '21000', 'city': 'Dijon', 'country': 'France', 'facility': 'CHU Dijon Bourgogne', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Dijon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}