ATTR Amyloidosis With CardiomyopathyNCT06836011
A Multicenter Study on Atrioventricular Regurgitation in Transthyretin Amyloid Cardiomyopathy: Definition, Prevalence, and Prognostic Impact.
An observational study of ATTR Amyloidosis With Cardiomyopathy and ATTR-CM, run by Medical University of Vienna at 8 sites in 4 countries.
Trial summary
The objective of this prospective registry study is to comprehensively characterize the prevalence, (semi-) quantitative parameters, and associated clinical outcomes of mitral (MR) and tricuspid regurgitation (TR) in patients diagnosed with transthyretin amyloid cardiomyopathy (ATTR-CM). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ATTR Amyloidosis With Cardiomyopathy, ATTR-CM, ATTR Amyloidosis Wild Type
- How many people
- 600 participants
- Where
- 8 sitesin 4 countries
- Study dates
- 1 Jan 2025to 31 Dec 2026
- 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: This observational study will include patients diagnosed with transthyretin amyloid cardiomyopathy (ATTR-CM) from international specialized cardiac amyloidosis referral centers. The study population will encompass both wild-type and hereditary ATTR-CM patients, ensuring representation of diverse disease phenotypes. Data collection will be standardized across centers, with echocardiographic assessments performed in accordance with the dedicated study protocol. The inclusion of multiple international centers will enhance the generalizability of findings across different healthcare systems and patient populations.
Who may be able to join
- Diagnosis of ATTR-CM according to current diagnostic criteria
- Comprehensive baseline echocardiographic assessment, including (semi-)quantitative mitral and tricuspid regurgitation (MR/TR) parameters, performed within ±6 months of diagnosis
- Age ≥ 18 years
- Willingness to participate in the study and provide informed consent
Who cannot join
- Severe aortic valve disease requiring intervention
- Inability to provide informed consent or participate in study follow-up
Trial locations and contacts
8 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 4 countries
Italy3 sites, 3 recruiting
- Recruiting
Institute of Cardiology, ASST Spedali Civili di Brescia, Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health, University of Brescia
Brescia, 25100
Marianna Adamo, Assoc.-Prof. Dr., 0000, mariannaadamo@hotmail.com
Marianna Adamo, Assoc.-Prof. Dr.
- Recruiting
Cardiologic Centre, Azienda Ospedaliero Universitaria di Ferrara
Ferrara, 44121
Matteo Serenelli, Dr., 0000, matteoserenelli@gmail.com
Matteo Serenelli, Dr.
- Recruiting
Center for Diagnosis and Treatment of Cardiomyopathies, Cardiovascular Department, Azienda Sanitaria Universitaria Giuliano-Isontina (ASUGI), University of Trieste
Trieste, 34100
Marco Merlo, Prof. Dr., +39 040 3994875, marco.merlo79@gmail.com
Marco Merlo, Prof. Dr.
Austria2 sites, 2 recruiting
- Recruiting
Medical University of Graz
Graz, Styria, 8010
Nicolas D Verheyen, Res.Prof. Priv.-Doz. DDr., +43 (0)316 385 30173, nicolas.verheyen@medunigraz.at
Nicolas D Verheyen, Res.Prof. Priv.-Doz. DDr.
- Recruiting
Department of Internal Medicine II, Medical University of Vienna
Vienna, 1090
Christian Nitsche, Priv.-Doz. Dr., PhD, +4314040048590, christian.nitsche@meduniwien.ac.at
Christian Nitsche, Priv.-Doz. Dr., PhD
Germany2 sites, 2 recruiting
- Recruiting
Department of Cardiology, University Hospital Frankfurt, Goethe University
Frankfurt am Main, Hesse, 60596
Maria Papathanasiou, Priv.-Doz. Dr. med., +496963017387, maria.papathanasiou@herz-frankfurt.de
Maria Papathanasiou, Priv.-Doz. Dr. med.
- Recruiting
Medizinische Klinik und Poliklinik I, Klinikum der Universitaet Muenchen, Ludwig-Maximilians-University
Munich, Bavaria, 81377
Stephanie Bieber, Dr. med., 0000, stephanie.bieber@med.uni-muenchen.de
Stephanie Bieber, Dr. med.
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Center Utrecht
Utrecht, 3450
Marish I.F.J. Oerlemans, Ass. Prof. Dr., 0000, moerlem4@umcutrecht.nl
Marish I.F.J. Oerlemans, Ass. Prof. Dr.
About this study
Official title: Definition and Prognosis of Atrioventricular Regurgitation in Transthyretin Amyloid Cardiomyopathy - a Prospective International Multicenter Study
The objective of this prospective registry study is to comprehensively characterize the prevalence, (semi-) quantitative parameters, and associated clinical outcomes of mitral (MR) and tricuspid regurgitation (TR) in patients diagnosed with transthyretin amyloid cardiomyopathy (ATTR-CM). The study further aims to develop and implement new grading standards for the quantitative assessment of regurgitation severity, tailored to the distinct hemodynamic profile of ATTR-CM. This approach seeks to address the limitations of current regurgitation severity classifications, which do not adequately reflect the unique pathophysiology of a restrictive phenotype as seen in ATTR-CM.
- Conditions
- ATTR Amyloidosis With Cardiomyopathy, ATTR-CM, ATTR Amyloidosis Wild Type, Mitral Regurgitation, Tricuspid Regurgitation
- Keywords
- ATTR-CM, ATTR amyloidosis, Tricuspid Regurgitation, Mitral Regurgitation
- Medical subject headings
- Mitral Valve Insufficiency, Tricuspid Valve Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Assessment of all-cause mortality in patients with ATTR-CM, stratified by baseline quantitative and semiquantitative measures of mitral and tricuspid regurgitation severity
Measured: up to 60 months
Secondary outcomes (2)
Cardiovscular mortality
Measured: up to 60 months
Heart Failure Hospitalization
Time to first heart failure hospitalization Rate of heart failure hospitalizations
Measured: up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start1 Jan 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ATTR Amyloidosis With CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Nitsche, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06836011
- Sponsor's protocol ID
- ATTR-CM-AVR-2025-001
- Status last verified
- Feb 2025
- First submitted
- 14 Feb 2025
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Dona C, Nitsche C, Koschutnik M, Heitzinger G, Mascherbauer K, Kammerlander AA, Dannenberg V, Halavina K, Rettl R, Duca F, Traub-Weidinger T, Puchinger J, Gunacker PC, Lamm G, Vock P, Lileg B, Philipp V, Staudenherz A, Calabretta R, Hacker M, Agis H, Bartko P, Hengstenberg C, Fontana M, Goliasch G, Mascherbauer J. Unveiling Cardiac Amyloidosis, its Characteristics, and Outcomes Among Patients With MR Undergoing Transcatheter Edge-to-Edge MV Repair. JACC Cardiovasc Interv. 2022 Sep 12;15(17):1748-1758. doi: 10.1016/j.jcin.2022.06.009. Epub 2022 Aug 22.
PubMed 36008266Hauptmann L, Kronberger C, Schwarting SK, Tomasoni D, Schlender LS, Koschatko S, Autherith M, Jantsch C, Demirel C, Duca F, Kammerlander A, Bordignon L, Guidi Colombi G, Schwegel N, Serenelli M, Porcari A, Muller SA, Verheyen N, Oerlemans MIFJ, Papathanasiou M, Hengstenberg C, Merlo M, Hausleiter J, Adamo M, Bartko PE, Nitsche C. Definition and Prognosis of Mitral Regurgitation in Transthyretin Amyloid Cardiomyopathy: A Multicenter International Cohort Study. Circulation. 2026 Oct 13. doi: 10.1161/CIRCULATIONAHA.125.079085. Online ahead of print.
PubMed 42866868
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Definition and Prognosis of Atrioventricular Regurgitation in Transthyretin Amyloid Cardiomyopathy - a Prospective International Multicenter Study
- ClinicalTrials.gov ID
- NCT06836011
- Acronym / sponsor ID
- ATTR-CM-AVR-2025-001
- Conditions
- ATTR Amyloidosis With Cardiomyopathy, ATTR-CM, ATTR Amyloidosis Wild Type, Mitral Regurgitation, Tricuspid Regurgitation
- Keywords
- ATTR-CM, ATTR amyloidosis, Tricuspid Regurgitation, Mitral Regurgitation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 Feb 2025 (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 objective of this prospective registry study is to comprehensively characterize the prevalence, (semi-) quantitative parameters, and associated clinical outcomes of mitral (MR) and tricuspid regurgitation (TR) in patients diagnosed with transthyretin amyloid cardiomyopathy (ATTR-CM). The study further aims to develop and implement new grading standards for the quantitative assessment of regurgitation severity, tailored to the distinct hemodynamic profile of ATTR-CM. This approach seeks to address the limitations of current regurgitation severity classifications, which do not adequately reflect the unique pathophysiology of a restrictive phenotype as seen in ATTR-CM.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This observational study will include patients diagnosed with transthyretin amyloid cardiomyopathy (ATTR-CM) from international specialized cardiac amyloidosis referral centers. The study population will encompass both wild-type and hereditary ATTR-CM patients, ensuring representation of diverse disease phenotypes. Data collection will be standardized across centers, with echocardiographic assessments performed in accordance with the dedicated study protocol. The inclusion of multiple international centers will enhance the generalizability of findings across different healthcare systems and patient populations.
Key inclusion criteria (4 listed)
- Diagnosis of ATTR-CM according to current diagnostic criteria
- Comprehensive baseline echocardiographic assessment, including (semi-)quantitative mitral and tricuspid regurgitation (MR/TR) parameters, performed within ±6 months of diagnosis
- Age ≥ 18 years
- Willingness to participate in the study and provide informed consent
Key exclusion criteria (2 listed)
- Severe aortic valve disease requiring intervention
- Inability to provide informed consent or participate in study follow-up
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: up to 60 months
Assessment of all-cause mortality in patients with ATTR-CM, stratified by baseline quantitative and semiquantitative measures of mitral and tricuspid regurgitation severity
2 secondary outcomes
Cardiovscular mortality
Time frame: up to 60 months
Heart Failure Hospitalization
Time frame: up to 60 months
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 19 Feb 2025.
- Background: PubMed 36008266Dona C, Nitsche C, Koschutnik M, Heitzinger G, Mascherbauer K, Kammerlander AA, Dannenberg V, Halavina K, Rettl R, Duca F, Traub-Weidinger T, Puchinger J, Gunacker PC, Lamm G, Vock P, Lileg B, Philipp V, Staudenherz A, Calabretta R, Hacker M, Agis H, Bartko P, Hengstenberg C, Fontana M, Goliasch G, Mascherbauer J. Unveiling Cardiac Amyloidosis, its Characteristics, and Outcomes Among Patients With MR Undergoing Transcatheter Edge-to-Edge MV Repair. JACC Cardiovasc Interv. 2022 Sep 12;15(17):1748-1758. doi: 10.1016/j.jcin.2022.06.009. Epub 2022 Aug 22.
- Derived from this study: PubMed 42866868Hauptmann L, Kronberger C, Schwarting SK, Tomasoni D, Schlender LS, Koschatko S, Autherith M, Jantsch C, Demirel C, Duca F, Kammerlander A, Bordignon L, Guidi Colombi G, Schwegel N, Serenelli M, Porcari A, Muller SA, Verheyen N, Oerlemans MIFJ, Papathanasiou M, Hengstenberg C, Merlo M, Hausleiter J, Adamo M, Bartko PE, Nitsche C. Definition and Prognosis of Mitral Regurgitation in Transthyretin Amyloid Cardiomyopathy: A Multicenter International Cohort Study. Circulation. 2026 Oct 13. doi: 10.1161/CIRCULATIONAHA.125.079085. Online ahead of print.
- Individual participant dataSharing planned: Undecided
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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.
8 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ATTR Amyloidosis With Cardiomyopathy and ATTR-CM, run by Medical University of Vienna at 8 sites in 4 countries.
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 4 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 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Italy, Austria, Germany, Netherlands. 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 Christian Nitsche, Priv.-Doz. Dr., PhD (+4314040048590, christian.nitsche@meduniwien.ac.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: up to 60 months). 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 NCT06836011, which also lists 2 linked publications.
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 19 Feb 2025; AzTrials last refreshed its copy on 8 Nov 2026.