Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2025-12-25 @ 9:11 PM
Study NCT ID:
NCT06129656
Status:
RECRUITING
Last Update Posted:
2023-11-13
First Post:
2023-10-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cardiac Amyloidosis Registry of University Hospital Leipzig
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D028227', 'term': 'Amyloid Neuropathies, Familial'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D002313', 'term': 'Cardiomyopathy, Restrictive'}], 'ancestors': [{'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D017772', 'term': 'Amyloid Neuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D028226', 'term': 'Amyloidosis, Familial'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D000686', 'term': 'Amyloidosis'}, {'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D009202', 'term': 'Cardiomyopathies'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'targetDuration': '20 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2033-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-08', 'studyFirstSubmitDate': '2023-10-19', 'studyFirstSubmitQcDate': '2023-11-08', 'lastUpdatePostDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2033-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All-cause and cardiac mortality', 'timeFrame': '10 years', 'description': 'Mortality'}, {'measure': 'Cumulative rate of patients with worsening heart failure', 'timeFrame': '10 years', 'description': 'Heart failure endpoint'}, {'measure': 'Rate of any hospitalizations', 'timeFrame': '10 years', 'description': 'Record of any clinical events requiring hospitalization'}, {'measure': 'Change in left ventricular ejection fraction', 'timeFrame': 'Every 6-12 months over 10 years', 'description': 'Change in LVEF assessed by echocardiography or cardiac MRI'}, {'measure': 'Change in left ventricular wall thickness', 'timeFrame': 'Every 6-12 months over 10 years', 'description': 'Change in left ventricular wall thickness/ mass assessed by echocardiography or cardiac MRI'}, {'measure': 'Change in systolic arterial pressure', 'timeFrame': 'Every 6-12 months over 10 years', 'description': 'Change in sPAP assessed by echocardiography'}, {'measure': 'Change in T1 values', 'timeFrame': 'Approx. every 12 months over 10 years', 'description': 'Change in T1 values assessed by cardiac MRI'}, {'measure': 'Change in extracellular volume values', 'timeFrame': 'Approx. every 12 months over 10 years', 'description': 'Change in ECV assessed by cardiac MRI'}, {'measure': 'Change in N-Terminal Pro-B-Type Natriuretic Peptide over time', 'timeFrame': 'Every 3-6 months over 10 years', 'description': 'Change in serum concentration of NT-proBNP'}, {'measure': 'Change in high-sensitivity cardiac troponin T over time', 'timeFrame': 'Every 3-6 months over 10 years', 'description': 'Change in serum concentration of hs-cTnT'}, {'measure': 'Changes in medical treatment for heart failure', 'timeFrame': 'Every 3-6 months over 10 years', 'description': 'Changes in heart failure medication (i.e. diuretics, beta-blocker, renin-angiotensin system inhibitors, mineralocorticoid receptor antagonists, sodium glucose cotransporter type 2 inhibitors) as well as specific treatment for amyloidosis (e.g. tafamidis) is recorded.'}], 'secondaryOutcomes': [{'measure': 'Prevalence and incidence of cardiac and non-cardiac comorbidities', 'timeFrame': 'Every 3-6 months over 10 years', 'description': 'Medical history and reports regarding any comorbidities and previous treatment will be assessed in detail at inclusion. Patients are asked for new comorbidities and new treatments at every visit.'}, {'measure': 'New York Heart Association (NYHA) class over time', 'timeFrame': 'Every 3-6 months over 10 years', 'description': 'As parameter of clinical status'}, {'measure': 'Functional capacity over time', 'timeFrame': 'Every 3-6 months over 10 years', 'description': 'Measured using 6 minute walk test'}, {'measure': 'Quality of life over time', 'timeFrame': 'Every 3-6 months over 10 years', 'description': 'Measured via questionnaire (e.g. KCCQ)'}, {'measure': 'Vital signs over time', 'timeFrame': 'Every 3-6 months over 10 years', 'description': 'Blood pressure'}, {'measure': 'Clinical signs of congestion over time', 'timeFrame': 'Every 3-6 months over 10 years', 'description': 'E.g. edema, jugular venous distension, crackles on lung auscultation'}, {'measure': 'Number of cardiovascular interventions', 'timeFrame': 'Monitoring continuously over 10 years', 'description': 'Indication, efficacy and safety of any cardiovascular intervention will be recorded, such as rate of pacemaker implantations, numbers of valve procedures (aortic valve implantation, mitral or tricuspid valve clipping), left atrial appendage occluder implantation, electrophysiological studies and ablation procedures'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['heart failure', 'cardiac amyloidosis', 'restrictive cardiomyopathy'], 'conditions': ['Cardiac Amyloidosis']}, 'descriptionModule': {'briefSummary': 'This is a clinical registry of patients with cardiac amyloidosis being treated at University Hospital Leipzig. The aim of the registry is to collect detailed information about clinical events, symptoms, imaging, biomarkers, comorbidities, and treatment from routine patient management which would not be provided by randomized clinical trails.', 'detailedDescription': 'Cardiac amyloidosis is increasingly diagnosed since awareness of the disease and therapeutic options increase. There is evidence from clinical trials about warning signs ("red flags"), diagnostic algorithms, and evidence for specific treatment. However, patients in randomized clinical studies are highly selected and do not necessarily reflect clinical practise. Furthermore, large clinical trials do not account for national medical care differences nor provide data about long-term outcome and the associations with comorbidities.\n\nClinical registries may reflect broad clinical practise and help to characterize cardiac amyloidosis in terms of epidemiology, application of diagnostic methods, the impact of comorbidities, and real-world clinical course. Furthermore, clinical registry studies may validate data from randomized clinical trials, provide information on implementation of treatment, the quality of interventions, monitoring patients during treatment, and inform about the safety of procedures.\n\nThe cardiac amyloidosis registry aims to collect data from the routine clinical management of patients with cardiac amyloidosis at the tertiary care University Hospital Leipzig. In particular, obtaining data about clinical events of heart disease, hemodynamic measures from echocardiography and circulation biomarkers, cardiac morphology from different imaging methods, clinical status, functional capacity, quality of life, and impact of comorbidities during the course of the disease will be the goal of this registry.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients with confirmed cardiac amyloidosis who are beeing treated at Department of Cardiology at University Hospital Leipzig.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed cardiac amyloidosis according to current standards\n\nExclusion Criteria:\n\n* refusal to participate'}, 'identificationModule': {'nctId': 'NCT06129656', 'briefTitle': 'Cardiac Amyloidosis Registry of University Hospital Leipzig', 'organization': {'class': 'OTHER', 'fullName': 'University of Leipzig'}, 'officialTitle': 'Cardiac Amyloidosis Registry of University Hospital Leipzig', 'orgStudyIdInfo': {'id': 'UKL_CA_registry'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cardiac Amyloidosis', 'description': 'Patients with diagnosed cardiac amyloidosis being treated at Leipzig University Hospital.', 'interventionNames': ['Other: Routine diagnostics', 'Other: Routine treatment']}], 'interventions': [{'name': 'Routine diagnostics', 'type': 'OTHER', 'description': 'Data collection of routine diagnostics', 'armGroupLabels': ['Cardiac Amyloidosis']}, {'name': 'Routine treatment', 'type': 'OTHER', 'description': 'Data collection of routine treatment', 'armGroupLabels': ['Cardiac Amyloidosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04103', 'city': 'Leipzig', 'state': 'Saxony', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'University Hospital Leipzig', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}], 'centralContacts': [{'name': 'Daniel Lavall, MD', 'role': 'CONTACT', 'email': 'daniel.lavall@medizin.uni-leipzig.de', 'phone': '+493419712650'}, {'name': 'Romy Gessner, MD', 'role': 'CONTACT', 'email': 'romy.gessner@medizin.uni-leipzig.de', 'phone': '+493419712650'}], 'overallOfficials': [{'name': 'Daniel Lavall, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Leipzig'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Leipzig', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}