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

NCT06836011 · tracked via the Priya Life Science Germany tracker

Sponsor

Medical University of Vienna

Phase

Observational

Started

2025-01-01

Last updated

2025-02-19

Condition(s) studied

ATTR Amyloidosis With CardiomyopathyATTR-CMATTR Amyloidosis Wild TypeMitral RegurgitationTricuspid Regurgitation

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

All-cause mortality — 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

Trial sites (8)

Facility	City	Region	Status
Medical University of Graz	Graz	Styria	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	Recruiting
Department of Cardiology, University Hospital Frankfurt, Goethe University	Frankfurt am Main	Hesse	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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06836011 on ClinicalTrials.gov ↗ ← All trials in Germany