Austrian Hypertrophic Cardiomyopathy Registry

Medical University of Graz

Status: Enrolling

Conditions: Hypertrophic Cardiomyopathy

Study type: Observational

Funder types: Other

Identifiers

NCT06368518

ID01/2024/MZHCM-Reg/NV

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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