Clinical trial Recruiting at 8 sites Observational Ages 18 and up

Understanding Atrioventricular Regurgitation in ATTR Amyloid Cardiomyopathy

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

Run by Medical University of Vienna · NCT06836011 · Data updated 2026-11-12

This study is trying to understand how common certain heart valve problems are in people with ATTR amyloid cardiomyopathy and create better ways to measure their severity.

More Mitral Regurgitation trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment600 (estimated)
SponsorMedical University of Vienna
Academic / other
Locations8 sites (Graz, Styria and 7 other locations)
StatusRecruiting
StartedJanuary 1, 2025
Main results expectedDecember 31, 2025
Study endsDecember 31, 2026
Registry record updatedFebruary 19, 2025
Trial IDNCT06836011 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include adults aged 18 and older diagnosed with ATTR-CM who can provide informed consent.

Probably not a fit

Patients with severe aortic valve disease requiring intervention or those unable to participate in follow-up will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to characterize the prevalence and clinical outcomes of mitral and tricuspid regurgitation in patients diagnosed with transthyretin amyloid cardiomyopathy (ATTR-CM). It will develop new grading standards for assessing regurgitation severity that are tailored to the unique hemodynamic profile of ATTR-CM. By conducting a comprehensive baseline echocardiographic assessment, the study seeks to address the limitations of current classifications that do not adequately reflect the condition's pathophysiology.

Why it matters

Potential benefit: If successful, this study could lead to improved diagnostic criteria and treatment strategies for patients with ATTR-CM and associated regurgitation.

How similar studies have gone: While this study addresses a specific aspect of ATTR-CM, similar studies have shown promise in improving understanding and management of cardiac conditions, suggesting potential for success.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Medical University of Graz
    Graz, Styria, Austria
    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, Germany
    Recruiting
  • Department of Cardiology, University Hospital Frankfurt, Goethe University
    Frankfurt am Main, Hesse, Germany
    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
Show 2 more locations
  • 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

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.