Austrian Hypertrophic Cardiomyopathy Registry

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06368518

Enrollment

1000

Registered

2024-04-16

Start date

2024-03-08

Completion date

2044-03-31

Last updated

2025-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertrophic Cardiomyopathy

Keywords

Hypertrophic Cardiomyopathy, Left ventricular hypertrophy, Hypertrophic Phenotype

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
All cause mortality	Through study completion, on average 20 years	All cause mortality
Cardiovascular events	Through study completion, on average 20 years	Cardiovascular events

Countries

Austria

Contacts

Primary ContactNicolas D Verheyen, MD

nicolas.verheyen@medunigraz.at004331638530173

Backup ContactViktoria Santner, MD

viktoria.santner@medunigraz.at004331638531233

Outcome results