Hypertrophic CardiomyopathyNCT06368518
Austrian Hypertrophic Cardiomyopathy Registry
An observational study of Hypertrophic Cardiomyopathy, run by Medical University of Graz at 15 sites in Austria.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertrophic Cardiomyopathy
- How many people
- 1,000 participants
- Where
- 15 sitesAustria
- Study dates
- 8 Mar 2024to Mar 2044
- How long will I take part?
- 20 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population includes subjects who fulfill criteria of HCM and are treated in Austria.
Who may be able to join
- 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
Who cannot join
- Age < 18 years
- Known cardiac amyloidosis
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
Austria15 sites, 14 recruiting
- Recruiting
Hospital St. Josef Braunau
Braunau am Inn, Upper Austria, 5280
Johann Auer, MD, Johann.Auer@khbr.at
- Recruiting
Hospital Graz 2 West
Graz, Styria, 8020
Gert Waltl, MD, gert.waltl@kages.at
- Recruiting
Medical University of Graz
Graz, Styria, 8036
Nicolas D Verheyen, MD, 004331638530173, nicolas.verheyen@medunigraz.at
Viktoria Santner, MD, viktoria.santner@medunigraz.at
- Recruiting
Medical University of Innsbruck
Innsbruck, Tyrol, 6020
Marc-Michael Zaruba, MD, marc-michael.zaruba@tirol-kliniken.at
- Recruiting
Kepler University Hospital Linz
Linz, Linz, 4021
Christian Reiter, MD, christian.reiter@kepleruniklinikum.at
- Recruiting
Ordensklinikum Linz
Linz, Upper Austria, 4020
Christian Ebner, MD, christian.ebner@ordensklinikum.at
- Recruiting
Paracelsus Medical University of Salzburg
Salzburg, State of Salzburg, 5020
Christina Granitz, MD, c.granitz@salk.at
- Recruiting
General Hospital St. Johann in Tirol
Sankt Johann in Tirol, 6380
Peter P Rainer, MD, peter.rainer@medunigraz.at
- Recruiting
University Hospital St. Pölten
Sankt Pölten, Lower Austria, 3100
Deddo Mörtl, MD, Deddo.Moertl@stpoelten.lknoe.at
- Recruiting
Clinic Cardinal Schwarzenberg
Schwarzach im Pongau, State of Salzburg, 5620
Anna Rab, MD, Anna.rab@icloud.com
- Recruiting
Medical University of Vienna
Vienna, State of Vienna, 1090
Daniel Dalos, MD, daniel.dalos@meduniwien.ac.at
- Active, not recruiting
Favoriten Clinic Vienna
Vienna, State of Vienna, 1100
- Recruiting
Klinik Ottakring
Vienna, State of Vienna
Stephan Dobner, MD, stephandobner@me.com
- Recruiting
Clinic Wels-Grieskirchen
Wels-Grieskirchen, 4600
Thomas Weber, MD, thomas.weber3@liwest.at
- Recruiting
Hospital Landesklinikum Wiener Neustadt
Wiener Neustadt, Lower Austria, 2700
Martin Grübler, MD, martin.gruebler@gmx.net
About this study
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.
Read the 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.
- Conditions
- Hypertrophic Cardiomyopathy
- Keywords
- Hypertrophic Cardiomyopathy, Left ventricular hypertrophy, Hypertrophic Phenotype
- Medical subject headings
- Cardiomyopathy, Hypertrophic, Hypertrophy, Left Ventricular
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality
All cause mortality
Measured: Through study completion, on average 20 years
Cardiovascular events
Cardiovascular events
Measured: Through study completion, on average 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start8 Mar 2024
- Primary completionMar 2044 (estimated)
- Study completionMar 2044 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypertrophic CardiomyopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 20 Years
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicolas Dominik Verheyen, MD, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06368518
- Sponsor's protocol ID
- ID01/2024/MZHCM-Reg/NV
- Status last verified
- Nov 2025
- First submitted
- 10 Apr 2024
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Santner V, Granitz C, Grubler MR, Dalos D, Reiter C, Zaruba MM, Auer J, Moertl D, Rab A, Rainer PP, Waltl G, Ebner C, Weber T, Bonderman D, Dobner S, Tuppinger H, Holler V, Schwegel N, Ablasser K, Zirlik A, Graf A, Gharibeh S, Lanzerstorfer J, Worgotter K, Mann C, Masood S, Meledeth C, Steinwender C, Logtenberg A, Messner M, Primus C, Auersperg P, Mackova L, Baurecht C, Winkler S, Schneiderbauer-Porod S, Danninger K, Charwat-Resl S, Harbich P, Krenn R, Verheyen N. The prospective Austrian hypertrophic cardiomyopathy registry - design, methods and results of the run-in period. Heart Fail Rev. 2026 Apr 15;31(1):56. doi: 10.1007/s10741-026-10630-6.
PubMed 41984359
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Austrian Hypertrophic Cardiomyopathy Registry
- ClinicalTrials.gov ID
- NCT06368518
- Acronym / sponsor ID
- ID01/2024/MZHCM-Reg/NV
- Conditions
- Hypertrophic Cardiomyopathy
- Keywords
- Hypertrophic Cardiomyopathy, Left ventricular hypertrophy, Hypertrophic Phenotype
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 8 Mar 2024 (actual)
- Primary completion
- Mar 2044 (estimated)
- Study completion
- Mar 2044 (estimated)
- First posted
- 16 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 20 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes subjects who fulfill criteria of HCM and are treated in Austria.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Age < 18 years
- Known cardiac amyloidosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All cause mortality
Time frame: Through study completion, on average 20 years
All cause mortality
Cardiovascular events
Time frame: Through study completion, on average 20 years
Cardiovascular events
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Derived from this study: PubMed 41984359Santner V, Granitz C, Grubler MR, Dalos D, Reiter C, Zaruba MM, Auer J, Moertl D, Rab A, Rainer PP, Waltl G, Ebner C, Weber T, Bonderman D, Dobner S, Tuppinger H, Holler V, Schwegel N, Ablasser K, Zirlik A, Graf A, Gharibeh S, Lanzerstorfer J, Worgotter K, Mann C, Masood S, Meledeth C, Steinwender C, Logtenberg A, Messner M, Primus C, Auersperg P, Mackova L, Baurecht C, Winkler S, Schneiderbauer-Porod S, Danninger K, Charwat-Resl S, Harbich P, Krenn R, Verheyen N. The prospective Austrian hypertrophic cardiomyopathy registry - design, methods and results of the run-in period. Heart Fail Rev. 2026 Apr 15;31(1):56. doi: 10.1007/s10741-026-10630-6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertrophic Cardiomyopathy, run by Medical University of Graz at 15 sites in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicolas D Verheyen, MD (004331638530173, nicolas.verheyen@medunigraz.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All cause mortality (time frame: Through study completion, on average 20 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06368518, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.