Ignite Creation Date:
2025-12-25 @ 12:54 AM
Ignite Modification Date:
2026-01-04 @ 4:39 PM
Study NCT ID:
NCT02971267
Status:
RECRUITING
Last Update Posted:
2021-10-01
First Post:
2016-11-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Follow-up of the Cardiomyopathy Cohort SFB/TR19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D009205', 'term': 'Myocarditis'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D057832', 'term': 'Watchful Waiting'}], 'ancestors': [{'id': 'D017063', 'term': 'Outcome Assessment, Health Care'}, {'id': 'D010043', 'term': 'Outcome and Process Assessment, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-30', 'studyFirstSubmitDate': '2016-11-09', 'studyFirstSubmitQcDate': '2016-11-19', 'lastUpdatePostDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of cardiovascular events', 'timeFrame': '1-year follow-ups up to 10 years', 'description': 'Number of hospitalization (HF based. all-cause), interventions (ICD, pacemaker), myocardial infarction'}], 'secondaryOutcomes': [{'measure': 'LVEF (left ventricular ejection fraction)', 'timeFrame': '1-year follow-ups up to 10 years', 'description': 'Left ventricular ejection fraction at time of follow-ups (through study completion, every year)'}, {'measure': 'VO2peak', 'timeFrame': '1-year follow-ups up to 10 years', 'description': 'Exercise capacity by CPET (cardiopulmonary exercise testing)'}, {'measure': 'QOL', 'timeFrame': '1-year follow-ups up to 10 years', 'description': 'Quality of life by MLHF questionnaire'}, {'measure': 'Mortality', 'timeFrame': '1-year follow-ups up to 10 years', 'description': 'Mortality (HF-related, cardiovascular disease, all-cause mortality)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['heart failure', 'cardiomyopathy', 'myocarditis'], 'conditions': ['Cardiomyopathies', 'Heart Failure']}, 'descriptionModule': {'briefSummary': 'Follow-up of a cohort of inflammatory cardiomyopathy patients (suspected or validated inflammatory cardiomyopathy) recruited at baseline by the SFB-TR19 project. Standardized protocols will be used for the assessment of medical history and examinations, laboratory biomarkers, and the collection of various biomaterials for biobanking purposes.', 'detailedDescription': 'Periodical follow-up of a cohort of inflammatory cardiomyopathy patients (suspected or validated inflammatory cardiomyopathy) recruited at baseline by the SFB/TR19 project. Participants will be followed up at least every year - or more frequently based on clinical need. Standardized protocols will be used for the assessment of medical history and examinations, laboratory biomarkers, and the collection of various biomaterials for biobanking purposes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with suspected or validated inflammatory cardiomyopathy at baseline', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participation in baseline examination of SFB/TR19\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT02971267', 'acronym': 'SFB/TR19plus', 'briefTitle': 'Follow-up of the Cardiomyopathy Cohort SFB/TR19', 'organization': {'class': 'OTHER', 'fullName': 'University Medicine Greifswald'}, 'officialTitle': 'Follow-up of the Inflammatory Cardiomyopathy Cohort of SFB/TR19', 'orgStudyIdInfo': {'id': 'SFB/TR19plus-001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Observational', 'type': 'OTHER', 'description': 'None, observational only'}]}, 'contactsLocationsModule': {'locations': [{'zip': '17475', 'city': 'Greifswald', 'state': 'Mecklenburg-Vorpommern', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Marcus Dörr, MD', 'role': 'CONTACT', 'email': 'mdoerr@uni-greifswald.de', 'phone': '+49383486', 'phoneExt': '80500'}, {'name': 'Stephan B Felix, MD', 'role': 'CONTACT', 'email': 'felix@uni-greifswald.de', 'phone': '+49383486', 'phoneExt': '80500'}, {'name': 'Kristin Lehnert, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sabine Kaczmarek, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ann Louise Pedersen, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Department of Internal Medicine B, University Medicine Greifswald', 'geoPoint': {'lat': 54.08905, 'lon': 13.40244}}], 'centralContacts': [{'name': 'Marcus Dörr, MD', 'role': 'CONTACT', 'email': 'mdoerr@uni-greifswald.de', 'phone': '+49383486', 'phoneExt': '80500'}, {'name': 'Stephan B Felix, MD', 'role': 'CONTACT', 'email': 'felix@uni-greifswald.de', 'phone': '+49383486', 'phoneExt': '80500'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medicine Greifswald', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}