Ignite Creation Date:
2025-12-25 @ 4:43 AM
Ignite Modification Date:
2025-12-26 @ 3:44 AM
Study NCT ID:
NCT06368518
Status:
RECRUITING
Last Update Posted:
2025-12-05
First Post:
2024-04-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Austrian Hypertrophic Cardiomyopathy Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002312', 'term': 'Cardiomyopathy, Hypertrophic'}, {'id': 'D017379', 'term': 'Hypertrophy, Left Ventricular'}], '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'}, {'id': 'D006332', 'term': 'Cardiomegaly'}, {'id': 'D006984', 'term': 'Hypertrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'targetDuration': '20 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2044-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-27', 'studyFirstSubmitDate': '2024-04-10', 'studyFirstSubmitQcDate': '2024-04-12', 'lastUpdatePostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2044-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All cause mortality', 'timeFrame': 'Through study completion, on average 20 years', 'description': 'All cause mortality'}, {'measure': 'Cardiovascular events', 'timeFrame': 'Through study completion, on average 20 years', 'description': 'Cardiovascular events'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hypertrophic Cardiomyopathy', 'Left ventricular hypertrophy', 'Hypertrophic Phenotype'], 'conditions': ['Hypertrophic Cardiomyopathy']}, 'descriptionModule': {'briefSummary': 'The Austrian Hypertrophic Cardiomyopathy (HCM) Registry is a prospective, multicenter registry enrolling patients at multiple outpatient clinics across Austria including academic and non-academic centers. Patients will undergo a structured examination process including assessment for symptoms of HCM, past medical history, concomitant medication, family history and the presence of HCM-specific red flags. Furthermore, clinical data derived from electrocardiogram, echocardiography, laboratory analysis, and genetic testing will be collected focusing on a lean variable dictionary and, in addition, specific hypothesis-driven research parameters. All data are entered into an electronic case report form (eCRF) (Phoenix Clinical Trial Management System). In order to perform multicenter analyses, data can be extracted from the eCRF after approval by the steering committee.', 'detailedDescription': 'The Austrian Hypertrophic Cardiomyopathy (HCM) Registry is a prospective, multicenter registry enrolling patients at multiple outpatient clinics across Austria including academic and non-academic centers. Patients will undergo a structured examination process including assessment for symptoms of HCM, past medical history, concomitant medication, family history and the presence of HCM-specific red flags. Furthermore, clinical data derived from electrocardiogram, echocardiography, laboratory analysis, and genetic testing will be collected focusing on a lean variable dictionary and, in addition, specific hypothesis-driven research parameters. All data are entered into an electronic case report form (eCRF) (Phoenix Clinical Trial Management System). Every site will nominate one representative for the steering committee which will serve as the regulatory authority with the compentence to approve research and funding proposals.\n\nThe Austrian multicenter HCM Registry aims to facilitate a wide range of innovative cross-sectional and longitudinal epidemiological analyses unravelling gaps in evidence in HCM. The standardized clinical assessment might harmonize standards of clinical care in HCM patients in Austria.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study population includes subjects who fulfill criteria of HCM and are treated in Austria.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients admitted to the HCM outpatient clinic of participating centers of the HCM Registry\n* Interventricular septal thickness ≥ 13 mm and cardiomyopathy-specific red flags OR Interventricular septal thickness ≥ 15 mm not explainable by loading conditions OR Interventricular septal thickness ≥ 17 mm\n* Willingness and ability to provide signed informed consent form (ICF) prior to participation in any study-related procedures\n\nExclusion criteria:\n\n* Age \\< 18 years\n* Known cardiac amyloidosis'}, 'identificationModule': {'nctId': 'NCT06368518', 'briefTitle': 'Austrian Hypertrophic Cardiomyopathy Registry', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Graz'}, 'officialTitle': 'Austrian Hypertrophic Cardiomyopathy Registry', 'orgStudyIdInfo': {'id': 'ID01/2024/MZHCM-Reg/NV'}}, 'contactsLocationsModule': {'locations': [{'zip': '4021', 'city': 'Linz', 'state': 'Linz', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Christian Reiter, MD', 'role': 'CONTACT', 'email': 'christian.reiter@kepleruniklinikum.at'}], 'facility': 'Kepler University Hospital Linz', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'zip': '3100', 'city': 'Sankt Pölten', 'state': 'Lower Austria', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Deddo Mörtl, MD', 'role': 'CONTACT', 'email': 'Deddo.Moertl@stpoelten.lknoe.at'}], 'facility': 'University Hospital St. Pölten', 'geoPoint': {'lat': 48.20762, 'lon': 15.63725}}, {'zip': '2700', 'city': 'Wiener Neustadt', 'state': 'Lower Austria', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Martin Grübler, MD', 'role': 'CONTACT', 'phone': 'martin.gruebler@gmx.net'}], 'facility': 'Hospital Landesklinikum Wiener Neustadt', 'geoPoint': {'lat': 47.80485, 'lon': 16.23196}}, {'zip': '5020', 'city': 'Salzburg', 'state': 'Salzburg', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Christina Granitz, MD', 'role': 'CONTACT', 'email': 'c.granitz@salk.at'}], 'facility': 'Paracelsus Medical University of Salzburg', 'geoPoint': {'lat': 47.79941, 'lon': 13.04399}}, {'zip': '5620', 'city': 'Schwarzach im Pongau', 'state': 'Salzburg', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Anna Rab, MD', 'role': 'CONTACT', 'email': 'Anna.rab@icloud.com'}], 'facility': 'Clinic Cardinal Schwarzenberg', 'geoPoint': {'lat': 47.32048, 'lon': 13.15171}}, {'zip': '8020', 'city': 'Graz', 'state': 'Styria', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Gert Waltl, MD', 'role': 'CONTACT', 'email': 'gert.waltl@kages.at'}], 'facility': 'Hospital Graz 2 West', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'zip': '8036', 'city': 'Graz', 'state': 'Styria', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Nicolas D Verheyen, MD', 'role': 'CONTACT', 'email': 'nicolas.verheyen@medunigraz.at', 'phone': '004331638530173'}, {'name': 'Viktoria Santner, MD', 'role': 'CONTACT', 'email': 'viktoria.santner@medunigraz.at'}, {'name': 'Nicolas D Verheyen, MD, PHD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Viktoria Santner, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Nora Schwegel, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Medical University of Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'zip': '6020', 'city': 'Innsbruck', 'state': 'Tyrol', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Marc-Michael Zaruba, MD', 'role': 'CONTACT', 'email': 'marc-michael.zaruba@tirol-kliniken.at'}], 'facility': 'Medical University of Innsbruck', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'zip': '5280', 'city': 'Braunau am Inn', 'state': 'Upper Austria', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Johann Auer, MD', 'role': 'CONTACT', 'email': 'Johann.Auer@khbr.at'}], 'facility': 'Hospital St. Josef Braunau', 'geoPoint': {'lat': 48.25628, 'lon': 13.04343}}, {'zip': '4020', 'city': 'Linz', 'state': 'Upper Austria', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Christian Ebner, MD', 'role': 'CONTACT', 'email': 'christian.ebner@ordensklinikum.at'}], 'facility': 'Ordensklinikum Linz', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'zip': '1090', 'city': 'Vienna', 'state': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Daniel Dalos, MD', 'role': 'CONTACT', 'email': 'daniel.dalos@meduniwien.ac.at'}], 'facility': 'Medical University of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '1100', 'city': 'Vienna', 'state': 'Vienna', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Austria', 'facility': 'Favoriten Clinic Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Vienna', 'state': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Stephan Dobner, MD', 'role': 'CONTACT', 'email': 'stephandobner@me.com'}], 'facility': 'Klinik Ottakring', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '6380', 'city': 'Sankt Johann in Tirol', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Peter P Rainer, MD', 'role': 'CONTACT', 'email': 'peter.rainer@medunigraz.at'}], 'facility': 'General Hospital St. Johann in Tirol', 'geoPoint': {'lat': 47.5233, 'lon': 12.4232}}, {'zip': '4600', 'city': 'Wels-Grieskirchen', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Thomas Weber, MD', 'role': 'CONTACT', 'email': 'thomas.weber3@liwest.at'}], 'facility': 'Clinic Wels-Grieskirchen'}], 'centralContacts': [{'name': 'Nicolas D Verheyen, MD', 'role': 'CONTACT', 'email': 'nicolas.verheyen@medunigraz.at', 'phone': '004331638530173'}, {'name': 'Viktoria Santner, MD', 'role': 'CONTACT', 'email': 'viktoria.santner@medunigraz.at', 'phone': '004331638531233'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Graz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Nicolas Dominik Verheyen, MD', 'investigatorAffiliation': 'Medical University of Graz'}}}}