Austrian Hypertrophic Cardiomyopathy Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Hypertrophic Cardiomyopathy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Detailed description
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.
The 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.
Primary outcome measures
- All cause mortality [Time frame: Through study completion, on average 20 years]
- Cardiovascular events [Time frame: Through study completion, on average 20 years]
Eligibility criteria
Inclusion criteria
- Patients admitted to the HCM outpatient clinic of participating centers of the HCM Registry
- 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
- Willingness and ability to provide signed informed consent form (ICF) prior to participation in any study-related procedures
Exclusion criteria
- Age < 18 years
- Known cardiac amyloidosis
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Austria · 15 centers
- Kepler University Hospital Linz — Linz
- University Hospital St. Pölten — Sankt Pölten
- Hospital Landesklinikum Wiener Neustadt — Wiener Neustadt
- Paracelsus Medical University of Salzburg — Salzburg
- Clinic Cardinal Schwarzenberg — Schwarzach im Pongau
- Medical University of Vienna — Vienna
- Favoriten Clinic Vienna — Vienna
- Klinik Ottakring — Vienna
- … and 7 more centers
Publications
- Santner V, Granitz C, Grubler MR, Dalos D, Reiter C, Zaruba MM, Auer J, Moertl D, Rab A, Rainer PP, Waltl G, Ebner C, Weber T, Bonderman D, Dobner S, Tuppinger H, Holler V, Schwegel N, Ablasser K, Zirlik A, Graf A, Gharibeh S, Lanzerstorfer J, Worgotter K, Mann C, Masood S, Meledeth C, Steinwender C, Logtenberg A, Messner M, Primus C, Auersperg P, Mackova L, Baurecht C, Winkler S, Schneiderbauer-P PMID 41984359
Identifiers
NCT: NCT06368518 · ID01/2024/MZHCM-Reg/NV