- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06368518
Austrian Hypertrophic Cardiomyopathy Registry
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Nicolas D Verheyen, MD
- Phone Number: 004331638530173
- Email: nicolas.verheyen@medunigraz.at
Study Contact Backup
- Name: Viktoria Santner, MD
- Phone Number: 004331638531233
- Email: viktoria.santner@medunigraz.at
Study Locations
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-
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Sankt Johann in Tirol, Austria, 6380
- Recruiting
- General Hospital St. Johann in Tirol
-
Contact:
- Peter P Rainer, MD
- Email: peter.rainer@medunigraz.at
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Wels-Grieskirchen, Austria, 4600
- Recruiting
- Clinic Wels-Grieskirchen
-
Contact:
- Thomas Weber, MD
- Email: thomas.weber3@liwest.at
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Linz
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Linz, Linz, Austria, 4021
- Recruiting
- Kepler University Hospital Linz
-
Contact:
- Christian Reiter, MD
- Email: christian.reiter@kepleruniklinikum.at
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Lower Austria
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Sankt Pölten, Lower Austria, Austria, 3100
- Recruiting
- University hospital St. Pölten
-
Contact:
- Deddo Mörtl, MD
- Email: Deddo.Moertl@stpoelten.lknoe.at
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Wiener Neustadt, Lower Austria, Austria, 2700
- Recruiting
- Hospital Landesklinikum Wiener Neustadt
-
Contact:
- Martin Grübler, MD
- Phone Number: martin.gruebler@gmx.net
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-
Salzburg
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Salzburg, Salzburg, Austria, 5020
- Recruiting
- Paracelsus Medical University of Salzburg
-
Contact:
- Christina Granitz, MD
- Email: c.granitz@salk.at
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Schwarzach im Pongau, Salzburg, Austria, 5620
- Recruiting
- Clinic Cardinal Schwarzenberg
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Contact:
- Anna Rab, MD
- Email: Anna.rab@icloud.com
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Styria
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Graz, Styria, Austria, 8036
- Recruiting
- Medical University of Graz
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Sub-Investigator:
- Nora Schwegel, MD
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Contact:
- Viktoria Santner, MD
- Email: viktoria.santner@medunigraz.at
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Contact:
- Nicolas D Verheyen, MD
- Phone Number: 004331638530173
- Email: nicolas.verheyen@medunigraz.at
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Principal Investigator:
- Nicolas D Verheyen, MD, PHD
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Sub-Investigator:
- Viktoria Santner, MD
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Graz, Styria, Austria, 8020
- Recruiting
- Hospital Graz 2 West
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Contact:
- Gert Waltl, MD
- Email: gert.waltl@kages.at
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Tyrol
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Innsbruck, Tyrol, Austria, 6020
- Recruiting
- Medical University of Innsbruck
-
Contact:
- Marc-Michael Zaruba, MD
- Email: marc-michael.zaruba@tirol-kliniken.at
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Upper Austria
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Braunau am Inn, Upper Austria, Austria, 5280
- Recruiting
- Hospital St. Josef Braunau
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Contact:
- Johann Auer, MD
- Email: Johann.Auer@khbr.at
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Linz, Upper Austria, Austria, 4020
- Recruiting
- Ordensklinikum Linz
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Contact:
- Christian Ebner, MD
- Email: christian.ebner@ordensklinikum.at
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Vienna
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Vienna, Vienna, Austria, 1090
- Recruiting
- Medical University of Vienna
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Contact:
- Daniel Dalos, MD
- Email: daniel.dalos@meduniwien.ac.at
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Vienna, Vienna, Austria, 1100
- Active, not recruiting
- Favoriten Clinic Vienna
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Vienna, Vienna, Austria
- Recruiting
- Klinik Ottakring
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Contact:
- Stephan Dobner, MD
- Email: stephandobner@me.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
All cause mortality
Time Frame: Through study completion, on average 20 years
|
All cause mortality
|
Through study completion, on average 20 years
|
|
Cardiovascular events
Time Frame: Through study completion, on average 20 years
|
Cardiovascular events
|
Through study completion, on average 20 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Aortic Valve Disease
- Cardiovascular Diseases
- Pathological Conditions, Anatomical
- Heart Diseases
- Heart Valve Diseases
- Cardiomyopathies
- Aortic Stenosis, Subvalvular
- Aortic Valve Stenosis
- Cardiomegaly
- Hypertrophy
- Pathological Conditions, Signs and Symptoms
- Cardiomyopathy, Hypertrophic
- Hypertrophy, Left Ventricular
Other Study ID Numbers
- ID01/2024/MZHCM-Reg/NV
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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