Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2026-03-13 @ 8:28 PM
Study NCT ID:
NCT01729702
Status:
COMPLETED
Last Update Posted:
2014-03-26
First Post:
2012-11-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neurohormonal Parameters in Hypertrophic Cardiomyopathies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002312', 'term': 'Cardiomyopathy, Hypertrophic'}], 'ancestors': [{'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001020', 'term': 'Aortic Stenosis, Subvalvular'}, {'id': 'D001024', 'term': 'Aortic Valve Stenosis'}, {'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 131}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-25', 'studyFirstSubmitDate': '2012-11-15', 'studyFirstSubmitQcDate': '2012-11-15', 'lastUpdatePostDateStruct': {'date': '2014-03-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasmatic Neurohormonal measures: BNP - NT ProBNP - Troponine', 'timeFrame': 'Day 1 at rest and during exercise'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['1- Hypertrophic cardiomyopathy', '2- BNP', '3- NT-proBNP', '4- Neurohormons'], 'conditions': ['1- Primary (Sarcomeric) Hypertrophic Cardiomyopathy', '2- Obstructive Hypertrophic Cardiomyopathy', '3- Non Obstructive Hypertrophic Cardiomyopathy']}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to demonstrate that changes in plasma levels of circulating neurohormones (mainly BNP and NT-proBNP), measured at rest and post-exercise correlate with exercise functional limitation (assessed by exercise peak VO2) and exercise ultrasonic parameters (as left ventricular filling, obstruction, and mitral regurgitation)', 'detailedDescription': 'The secondary purposes are to study the kinetics of secretions of natriuretic peptides, and their relationships with extent of MRI myocardial fibrosis with the degree of exercise functional limitation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\- Age 18 to 75 years\n* Primary (sarcomeric) hypertrophic cardiomyopathy, obstructive or non obstructive, with studies of exercise peak oxygen consumption and cardiac MRI with gadolinium late-enhancement\n* Informed consent\n* Patient with a social insurance Patient at rest\n* \\- Age 18 to 75 years\n* Primary (sarcomeric) hypertrophic cardiomyopathy, obstructive or non obstructive\n* Informed consent\n* Patient with a social insurance\n\nExclusion Criteria:\n\n* \\- Insufficient echogenicity\n* Permanent atrial fibrillation\n* Complete BBB on the ECG\n* LVEF \\< 35 %\n* Previous septal ablation (surgical or percutaneous)\n* Simultaneous participation to another biomedical research\n\nIf exercise needed:\n\n* contraindication to exercise : hemodynamic instability, uncontrolled high blood pressure (\\>220/120 mmHg), severe aortic stenosis\n* Inability to exercise (muscular, pulmonary, elderly patient)'}, 'identificationModule': {'nctId': 'NCT01729702', 'acronym': 'REEF-CMH', 'briefTitle': 'Neurohormonal Parameters in Hypertrophic Cardiomyopathies', 'organization': {'class': 'OTHER', 'fullName': 'French Cardiology Society'}, 'officialTitle': 'Evaluation at Rest and Exercise of Clinical, Ultrasonic and Neurohormonal Parameters in Hypertrophic Cardiomyopathies', 'orgStudyIdInfo': {'id': '2008-08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'single group - consecutive patients', 'interventionNames': ['Other: blood sample collection']}], 'interventions': [{'name': 'blood sample collection', 'type': 'OTHER', 'armGroupLabels': ['single group - consecutive patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Européen Georges Pompidou', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Albert Hagège, MD-PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'HEGP - Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'French Cardiology Society', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}