RECRUITINGOBSERVATIONAL

A Multicenter Study on Atrioventricular Regurgitation in Transthyretin Amyloid Cardiomyopathy: Definition, Prevalence, and Prognostic Impact.

Definition and Prognosis of Atrioventricular Regurgitation in Transthyretin Amyloid Cardiomyopathy - a Prospective International Multicenter Study

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form Who Should NOT Join This Trial: - Severe aortic valve disease requiring intervention - Inability to provide willing to sign a consent form or participate in study follow-up Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * 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 Exclusion Criteria: * Severe aortic valve disease requiring intervention * Inability to provide informed consent or participate in study follow-up

Locations (8)

Medical University of Graz

Graz, Styria, Austria

Department of Internal Medicine II, Medical University of Vienna

Vienna, Austria

Medizinische Klinik und Poliklinik I, Klinikum der Universitaet Muenchen, Ludwig-Maximilians-University

Munich, Bavaria, Germany

Department of Cardiology, University Hospital Frankfurt, Goethe University

Frankfurt am Main, Hesse, Germany

Institute of Cardiology, ASST Spedali Civili di Brescia, Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health, University of Brescia

Brescia, Italy

Cardiologic Centre, Azienda Ospedaliero Universitaria di Ferrara

Ferrara, Italy

Center for Diagnosis and Treatment of Cardiomyopathies, Cardiovascular Department, Azienda Sanitaria Universitaria Giuliano-Isontina (ASUGI), University of Trieste

Trieste, Italy

University Medical Center Utrecht

Utrecht, Netherlands