Clinical trial NCT06368518: Austrian Hypertrophic Cardiomyopathy Registry
Official title: Austrian Hypertrophic Cardiomyopathy Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hypertrophic Cardiomyopathy
Keywords: Hypertrophic Cardiomyopathy
Left ventricular hypertrophy
Hypertrophic Phenotype
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2024-04-16
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population includes subjects who fulfill criteria of HCM and are treated in Austria.

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.

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

Primary outcomes:
measure: All cause mortality
timeFrame: Through study completion, on average 20 years
measure: Cardiovascular events
timeFrame: Through study completion, on average 20 years
Secondary outcomes:
Other outcomes:
Locations:
city: St.Pölten
country: Austria
facility: University Hospital St. Pölten
state: Niederösterreich
city: Wiener Neustadt
country: Austria
facility: Hospital Landesklinikum Wiener Neustadt
state: Niederösterreich
city: Braunau am Inn
country: Austria
facility: Hospital St. Josef Braunau
state: Oberösterreich
city: Linz
country: Austria
facility: Ordensklinikum Linz
state: Oberösterreich
city: Schwarzach im Pongau
country: Austria
facility: Clinic Cardinal Schwarzenberg
state: Salzburg
city: Graz
country: Austria
facility: Hospital Graz 2 West
state: Styria
city: Graz
country: Austria
facility: Medical University of Graz
state: Styria
city: Innsbruck
country: Austria
facility: Medical University of Innsbruck
state: Tirol
city: Linz
country: Austria
facility: Kepler University Hospital Linz
city: Salzburg
country: Austria
facility: Paracelsus Medical University of Salzburg
city: Sankt Johann In Tirol
country: Austria
facility: General Hospital St. Johann in Tirol
city: Vienna
country: Austria
facility: Medical University of Vienna
city: Vienna
country: Austria
facility: Favoriten Clinic Vienna
city: Wels-Grieskirchen
country: Austria
facility: Clinic Wels-Grieskirchen
Study officials:
References: