Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06368518
Status:
RECRUITING
Last Update Posted:
2024-04-16
First Post:
2024-04-10
Brief Title:
Austrian Hypertrophic Cardiomyopathy Registry
Sponsor:
Medical University of Graz
Organization:
Medical University of Graz
Study Overview
Official Title:
Austrian Hypertrophic Cardiomyopathy Registry
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None