Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2026-05-27 @ 2:53 AM
Study NCT ID:
NCT03572569
Status:
UNKNOWN
Last Update Posted:
2018-06-28
First Post:
2018-06-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Risk Stratification in Children and Adolescents With Primary Cardiomyopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D002311', 'term': 'Cardiomyopathy, Dilated'}, {'id': 'D002312', 'term': 'Cardiomyopathy, Hypertrophic'}, {'id': 'D002313', 'term': 'Cardiomyopathy, Restrictive'}, {'id': 'D019571', 'term': 'Arrhythmogenic Right Ventricular Dysplasia'}, {'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006332', 'term': 'Cardiomegaly'}, {'id': 'D000083083', 'term': 'Laminopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D001020', 'term': 'Aortic Stenosis, Subvalvular'}, {'id': 'D001024', 'term': 'Aortic Valve Stenosis'}, {'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'DNA; tissue'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'FAMILY_BASED'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-06-27', 'studyFirstSubmitDate': '2018-06-01', 'studyFirstSubmitQcDate': '2018-06-27', 'lastUpdatePostDateStruct': {'date': '2018-06-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'major cardiovascular events', 'timeFrame': 'from date of enrollment until the date of death, mechanical circulatory support or heart transplantation, assessed up to 8 years', 'description': 'death, need for mechanical circulatory support or heart transplantation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pediatrics', 'Cardiomyopathy', 'Heart failure', 'Risk stratification', 'Family screening', 'Genetics'], 'conditions': ['Primary Cardiomyopathy', 'Dilated Cardiomyopathy', 'Hypertrophic Cardiomyopathy', 'Left Ventricular Noncompaction', 'Restrictive Cardiomyopathy', 'Arrhythmogenic Right Ventricular Cardiomyopathy']}, 'referencesModule': {'references': [{'pmid': '35252369', 'type': 'DERIVED', 'citation': 'Al-Wakeel-Marquard N, Seidel F, Kuhnisch J, Kuehne T, Berger F, Messroghli DR, Klaassen S. Midwall Fibrosis and Cardiac Mechanics: Rigid Body Rotation Is a Novel Marker of Disease Severity in Pediatric Primary Dilated Cardiomyopathy. Front Cardiovasc Med. 2022 Feb 17;8:810005. doi: 10.3389/fcvm.2021.810005. eCollection 2021.'}, {'pmid': '31333075', 'type': 'DERIVED', 'citation': 'Al-Wakeel-Marquard N, Degener F, Herbst C, Kuhnisch J, Dartsch J, Schmitt B, Kuehne T, Messroghli D, Berger F, Klaassen S. RIKADA Study Reveals Risk Factors in Pediatric Primary Cardiomyopathy. J Am Heart Assoc. 2019 Aug 6;8(15):e012531. doi: 10.1161/JAHA.119.012531. Epub 2019 Jul 23.'}]}, 'descriptionModule': {'briefSummary': 'RIKADA is a prospective study performing systematic family screening including clinical and genetic testing in pediatric patients with primary cardiomyopathy and their first-degree relatives with the aim to facilitate risk stratification.', 'detailedDescription': 'RIKADA is a long-term prospective study performing in-depth phenotype and genotype characterization in children and adolescents with primary cardiomyopathy and their first-degree family members. Family screening contains complete cardiac work-up with medical history, physical examination, 12-lead-/Holter-electrocardiogram, cardiopulmonary exercise testing, echocardiography, cardiovascular magnetic resonance (CMR) and laboratory including genetic testing. The aim is to facilitate early identification of at-risk individuals and contribute to patient-specific follow-up and therapy regimes preventing progressive heart failure and arrhythmia in pediatric CMP.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Department of pediatric cardiology including outpatient department', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Index patients:\n\n * Age ≤18 years\n * written informed consent of parents/legal guardians\n * diagnosis of primary cardiomypathy:\n * DCM: left ventricular (LV) systolic dysfunction and dilatation greater than two standard deviations (SD) above the mean of a normal population\n * HCM: LV hypertrophy and septal wall thickness above two SD\n * RCM: diastolic dysfunction and concordant atrial enlargement\n * LVNC: separation of the myocardium into a compacted (C) and a non- compacted (NC) layer with an NC/C ratio \\>2 in echocardiography and/or \\>2.3 in CMR\n * ARVC: according to the revised Task Force Criteria\n2. First-degree family members (parents and siblings):\n\n * Age ≥3 years\n * written informed consent of parents/legal guardians and siblings ≥18 years\n\nExclusion Criteria:\n\n* unwillingness to give consent\n* myocardial inflammation / myocarditis\n* systemic disease with cardiac involvement (secondary cardiomyopathy)\n* structural congenital heart disease'}, 'identificationModule': {'nctId': 'NCT03572569', 'acronym': 'RIKADA', 'briefTitle': 'Risk Stratification in Children and Adolescents With Primary Cardiomyopathy', 'organization': {'class': 'OTHER', 'fullName': 'German Heart Institute'}, 'officialTitle': 'Risk Stratification in Children and Adolescents With Primary Cardiomyopathy', 'orgStudyIdInfo': {'id': 'A30127'}, 'secondaryIdInfos': [{'id': '81Z3100331', 'type': 'OTHER_GRANT', 'domain': 'DZHK (German Centre for Cardiovascular Research)'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Index patients', 'description': 'Patients ≤18 years with primary cardiomyopathy'}, {'label': 'First-degree family members', 'description': 'Parents and siblings of index patients'}]}, 'contactsLocationsModule': {'locations': [{'zip': '13353', 'city': 'Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Charité - Universitätsmedizin Berlin', 'role': 'CONTACT'}, {'name': 'Sabine Klaassen, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Charité - Universitätsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '13353', 'city': 'Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'German Heart Institute', 'role': 'CONTACT'}, {'name': 'Nadya Al-Wakeel - Marquard, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'German Heart Institute', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'centralContacts': [{'name': 'Sabine Klaassen, MD', 'role': 'CONTACT', 'email': 'klaassen@mdc-berlin.de', 'phone': '+49 30 450', 'phoneExt': '540656'}, {'name': 'Nadya Al-Wakeel-Marquard, MD', 'role': 'CONTACT', 'email': 'alwakeel@dhzb.de', 'phone': '+49 30 4593', 'phoneExt': '2883'}], 'overallOfficials': [{'name': 'Felix Berger, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'German Heart Institute'}, {'name': 'Sabine Klaassen, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Charite University, Berlin, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'German Heart Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}