Austrian HCM Registry

Hypertrophic Cardiomyopathy Clinical Trial

Official title:

Austrian Hypertrophic Cardiomyopathy Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06368518
• Other study ID #: ID01/2024/MZHCM-Reg/NV
• Status: Recruiting
• Start date: March 8, 2024
• Est. completion date: March 2034

Study information

• Verified date: April 2024
• Source: Medical University of Graz
• Contact: Nicolas Verheyen, MD, PHD
• Phone: 004331638530173
• Email: nicolas.verheyen[@]medunigraz.at
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 2034
• Est. primary completion date: March 2034
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Hypertrophic
• Hypertrophic Cardiomyopathy
• Hypertrophy

Locations

Country	Name	City	State
Austria	Medical University of Graz	Graz	Styria

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All cause mortality	All cause mortality	Through study completion, on average 10 years
Primary	Cardiovascular events	Cardiovascular events	Through study completion, on average 10 years