Austrian Hypertrophic Cardiomyopathy Registry

Recruiting

• Conditions: Hypertrophic Cardiomyopathy

• Registration Number: NCT06368518
• Lead Sponsor: Medical University of Graz

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.

Study Timeline

• Study Start: 2024-03-08
• Status Verified: 2024-04
• Study First Submitted: 2024-04-10
• Study First Submitted QC: 2024-04-12
• Study First Posted: 2024-04-16
• Last Update Submitted: 2024-10-04
• Last Update Posted: 2024-10-08
• Primary Completion: 2044-03
• Study Completion: 2044-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All cause mortality	Through study completion, on average 20 years	All cause mortality
Cardiovascular events	Through study completion, on average 20 years	Cardiovascular events

Trial Locations

Locations (14)

University Hospital St. Pölten; 🇦🇹 St.Pölten, Niederösterreich, Austria

Hospital Landesklinikum Wiener Neustadt; 🇦🇹 Wiener Neustadt, Niederösterreich, Austria

Hospital St. Josef Braunau; 🇦🇹 Braunau am Inn, Oberösterreich, Austria

Ordensklinikum Linz; 🇦🇹 Linz, Oberösterreich, Austria

Clinic Cardinal Schwarzenberg; 🇦🇹 Schwarzach im Pongau, Salzburg, Austria

Hospital Graz 2 West; 🇦🇹 Graz, Styria, Austria

Medical University of Innsbruck; 🇦🇹 Innsbruck, Tirol, Austria

Kepler University Hospital Linz; 🇦🇹 Linz, Austria

Paracelsus Medical University of Salzburg; 🇦🇹 Salzburg, Austria

General Hospital St. Johann in Tirol; 🇦🇹 Sankt Johann In Tirol, Austria

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