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

Medical University of Vienna600 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

600

Conditions

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

RECRUITING

Department of Internal Medicine II, Medical University of Vienna

Vienna, Austria

RECRUITING

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

Munich, Bavaria, Germany

RECRUITING

Department of Cardiology, University Hospital Frankfurt, Goethe University

Frankfurt am Main, Hesse, Germany

RECRUITING

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

Brescia, Italy

RECRUITING

Cardiologic Centre, Azienda Ospedaliero Universitaria di Ferrara

Ferrara, Italy

RECRUITING

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

Trieste, Italy

RECRUITING

University Medical Center Utrecht

Utrecht, Netherlands

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: up to 60 months

Secondary Outcomes

Cardiovscular mortality

Time frame: up to 60 months

Heart Failure Hospitalization

Time to first heart failure hospitalization Rate of heart failure hospitalizations

Time frame: up to 60 months

Central Contacts

Christian Nitsche, Priv.-Doz. Dr., PhD

CONTACT

+4314040048590 christian.nitsche@meduniwien.ac.at

Laurenz Hauptmann, Dr.

CONTACT

+4314040048590 Laurenz.hauptmann@meduniwien.ac.at