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

Recruitingn/aAges 18 Years - anyAllMedical University of Vienna
NCT06836011 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Not listed
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Where

8 sites
Medical University of Graz
Graz, 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, Germany
Department of Cardiology, University Hospital Frankfurt, Goethe University
Frankfurt am Main, 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
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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