Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2026-03-01 @ 2:45 AM
Study NCT ID:
NCT03969394
Status:
UNKNOWN
Last Update Posted:
2019-05-31
First Post:
2019-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Prognostic Role of the Right Ventricle in Patients With Heart Failure or Congenital Heart Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D013180', 'term': 'Sprains and Strains'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}], 'ancestors': [{'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2020-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-05-30', 'studyFirstSubmitDate': '2019-05-29', 'studyFirstSubmitQcDate': '2019-05-30', 'lastUpdatePostDateStruct': {'date': '2019-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'overall survival', 'timeFrame': '3 years'}], 'secondaryOutcomes': [{'measure': 'Heart Failure', 'timeFrame': '3 years', 'description': 'Hospitalization due to heart failure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['strain', 'MRI', 'echocardiography'], 'conditions': ['Heart Failure']}, 'referencesModule': {'references': [{'pmid': '33438438', 'type': 'DERIVED', 'citation': 'Houard L, Amzulescu MS, Colin G, Langet H, Militaru S, Rousseau MF, Ahn SA, Vanoverschelde JJ, Pouleur AC, Gerber BL. Prognostic Value of Pulmonary Transit Time by Cardiac Magnetic Resonance on Mortality and Heart Failure Hospitalization in Patients With Advanced Heart Failure and Reduced Ejection Fraction. Circ Cardiovasc Imaging. 2021 Jan;14(1):e011680. doi: 10.1161/CIRCIMAGING.120.011680. Epub 2021 Jan 13.'}]}, 'descriptionModule': {'briefSummary': 'The objectives are\n\n1. to validate quantification of 2D and 3D right ventricular strian measurements of right ventricular performance in cross comparison to cardiac MRI and to evaluate its relation to right ventricular fibrosis.\n2. to evaluate their prognostic value in patients with heart failure with either depressed or preserved ejection fraction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult Patients with heart failure\n\nExclusion Criteria:\n\n* Renal failure\n* Contraindications to Cardiac MRI'}, 'identificationModule': {'nctId': 'NCT03969394', 'acronym': 'RV-STRAIN', 'briefTitle': 'The Prognostic Role of the Right Ventricle in Patients With Heart Failure or Congenital Heart Disease', 'organization': {'class': 'OTHER', 'fullName': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain'}, 'officialTitle': 'The Prognostic Role of the Right Ventricle in Patients With Heart Failure or Congenital Heart Disease', 'orgStudyIdInfo': {'id': '2017/02MAR/117'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Heart Failure Patients', 'description': 'Patients with Heart Failure', 'interventionNames': ['Diagnostic Test: Medical imaging']}], 'interventions': [{'name': 'Medical imaging', 'type': 'DIAGNOSTIC_TEST', 'description': 'Medical Imaging consisting of 1 MRI and 1 echocardiography at baseline', 'armGroupLabels': ['Heart Failure Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1200', 'city': 'Brussels', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Bernhard Gerber, MD, PhD', 'role': 'CONTACT'}, {'name': 'Bernhard Gerber, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cliniques Universitaires Saint-Luc', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'centralContacts': [{'name': 'Bernhard Gerber, MD,PhD', 'role': 'CONTACT', 'email': 'Bernhard.Gerber@uclouvain.be', 'phone': '+3227642803'}], 'overallOfficials': [{'name': 'Bernhard Gerber, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fonds National de la Recherche Scientifique', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}