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

Last updated: February 14, 2025
Sponsor: Medical University of Vienna
Overall Status: Active - Recruiting

Phase

N/A

Condition

Amyloidosis

Vomiting

Circulation Disorders

Treatment

N/A

Clinical Study ID

NCT06836011
ATTR-CM-AVR-2025-001
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of ATTR-CM according to current diagnostic criteria

  • Comprehensive baseline echocardiographic assessment, including (semi-)quantitativemitral and tricuspid regurgitation (MR/TR) parameters, performed within ±6 months ofdiagnosis

  • Age ≥ 18 years

  • Willingness to participate in the study and provide informed consent

Exclusion

Exclusion Criteria:

  • Severe aortic valve disease requiring intervention

  • Inability to provide informed consent or participate in study follow-up

Study Design

Total Participants: 600
Study Start date:
January 01, 2025
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Medical University of Graz

    Graz, Styria 8010
    Austria

    Active - Recruiting

  • Department of Internal Medicine II, Medical University of Vienna

    Vienna, 1090
    Austria

    Active - Recruiting

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

    Munich, Bayern 81377
    Germany

    Active - Recruiting

  • Department of Cardiology, University Hospital Frankfurt, Goethe University

    Frankfurt am Main, Hessen 60596
    Germany

    Active - Recruiting

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

    Brescia, 25100
    Italy

    Active - Recruiting

  • Cardiologic Centre, Azienda Ospedaliero Universitaria di Ferrara

    Ferrara, 44121
    Italy

    Active - Recruiting

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

    Trieste, 34100
    Italy

    Active - Recruiting

  • University Medical Center Utrecht

    Utrecht, 3450
    Netherlands

    Active - Recruiting

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