RecruitingNCT06836011

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

Sponsor

Medical University of Vienna

Enrollment

600 participants

Start Date

Jan 1, 2025

Study Type

OBSERVATIONAL

Conditions

Tricuspid Regurgitation Mitral Regurgitation ATTR-CM ATTR Amyloidosis With Cardiomyopathy ATTR Amyloidosis Wild Type

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). 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.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

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 Criteria2

Severe aortic valve disease requiring intervention
Inability to provide informed consent or participate in study follow-up

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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

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NCT06836011