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

Recruiting

• Conditions: ATTR Amyloidosis With Cardiomyopathy; ATTR-CM; ATTR Amyloidosis Wild Type; Mitral Regurgitation; Tricuspid Regurgitation

• Registration Number: NCT06836011
• Lead Sponsor: Medical University of Vienna

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-01
• Status Verified: 2025-02
• Study First Submitted: 2025-02-14
• Study First Submitted QC: 2025-02-14
• Last Update Submitted: 2025-02-14
• Study First Posted: 2025-02-19
• Last Update Posted: 2025-02-19
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Cardiovscular mortality	up to 60 months
Heart Failure Hospitalization	up to 60 months	Time to first heart failure hospitalization Rate of heart failure hospitalizations

Trial Locations

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, Bayern, Germany

Department of Cardiology, University Hospital Frankfurt, Goethe University; 🇩🇪 Frankfurt am Main, Hessen, 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