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Studying heart valve leakage in people with transthyretin amyloid heart disease

Observes how valve leakage in the heart affects people with transthyretin amyloid cardiomyopathy.

Plain-language title generated from the registry record
Registry title: A Multicenter Study on Atrioventricular Regurgitation in Transthyretin Amyloid Cardiomyopathy: Definition, Prevalence, and Prognostic Impact.

Key facts

Where
Graz and Vienna, AustriaSee the 2 sites

Where in Austria

  • Medical University of GrazGraz, AustriaTaking people
  • Department of Internal Medicine II, Medical University of ViennaVienna, AustriaTaking people

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Trial details

Who runs it
Medical University of Vienna
Trial code
NCT06836011
Record updated
19 February 2025
Original description
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.Read full original descriptionShow less

Definition and Prognosis of Atrioventricular Regurgitation in Transthyretin Amyloid Cardiomyopathy - a Prospective International Multicenter Study

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.

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

ClinicalTrials.gov NCT06836011