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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | up to 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovscular mortality | up to 60 months | |
| Heart Failure Hospitalization | Time to first heart failure hospitalization Rate of heart failure hospitalizations | up to 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression of Atrioventricular Regurgitation | Change in mitral and tricuspid regurgitation severity over time and its impact on clinical outcomes. | At 12 and 24 months follow-up |
Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christian Nitsche, Priv.-Doz. Dr., PhD | Contact | +4314040048590 | christian.nitsche@meduniwien.ac.at | |
| Laurenz Hauptmann, Dr. | Contact | +4314040048590 | Laurenz.hauptmann@meduniwien.ac.at |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Graz | Recruiting | Graz | Styria | 8010 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36008266 | Background | 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. |
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| Department of Internal Medicine II, Medical University of Vienna | Recruiting | Vienna | 1090 | Austria |
|
| Medizinische Klinik und Poliklinik I, Klinikum der Universitaet Muenchen, Ludwig-Maximilians-University | Recruiting | Munich | Bavaria | 81377 | Germany |
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| Department of Cardiology, University Hospital Frankfurt, Goethe University | Recruiting | Frankfurt am Main | Hesse | 60596 | Germany |
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| Institute of Cardiology, ASST Spedali Civili di Brescia, Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health, University of Brescia | Recruiting | Brescia | 25100 | Italy |
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| Cardiologic Centre, Azienda Ospedaliero Universitaria di Ferrara | Recruiting | Ferrara | 44121 | Italy |
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| Center for Diagnosis and Treatment of Cardiomyopathies, Cardiovascular Department, Azienda Sanitaria Universitaria Giuliano-Isontina (ASUGI), University of Trieste | Recruiting | Trieste | 34100 | Italy |
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| University Medical Center Utrecht | Recruiting | Utrecht | 3450 | Netherlands |
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| ID | Term |
|---|---|
| D008944 | Mitral Valve Insufficiency |
| D014262 | Tricuspid Valve Insufficiency |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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