NCT06836011Recruiting
A Multicenter Study on Atrioventricular Regurgitation in Transthyretin Amyloid Cardiomyopathy: Definition, Prevalence, and Prognostic Impact.
Definition and Prognosis of Atrioventricular Regurgitation in Transthyretin Amyloid Cardiomyopathy - a Prospective International Multicenter Study
Source: ClinicalTrials.gov · Last updated 19 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 600 (estimated)
- First submitted
- 14 Feb 2025
- Start date
- 1 Jan 2025
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Medical University of Vienna
- Diseases
- Amyloidosis
- NCT number
- NCT06836011
What you commit to
- Study type: Observational
- Planned participants: 600
- From 1 Jan 2025 to the primary completion date, 31 Dec 2025
- 8 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Severe aortic valve disease requiring intervention
Other
- Inability to provide informed consent or participate in study follow-up
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University of Graz Coordinator of this site? Confirm its status | Graz | Austria | Recruiting |
| Department of Internal Medicine II, Medical University of Vienna Coordinator of this site? Confirm its status | Vienna | Austria | Recruiting |
| Department of Cardiology, University Hospital Frankfurt, Goethe University Coordinator of this site? Confirm its status | Frankfurt am Main | Germany | Recruiting |
| Medizinische Klinik und Poliklinik I, Klinikum der Universitaet Muenchen, Ludwig-Maximilians-University Coordinator of this site? Confirm its status | Munich | Germany | Recruiting |
| Institute of Cardiology, ASST Spedali Civili di Brescia, Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health, University of Brescia Coordinator of this site? Confirm its status | Brescia | Italy | Recruiting |
| Cardiologic Centre, Azienda Ospedaliero Universitaria di Ferrara Coordinator of this site? Confirm its status | Ferrara | Italy | Recruiting |
| Center for Diagnosis and Treatment of Cardiomyopathies, Cardiovascular Department, Azienda Sanitaria Universitaria Giuliano-Isontina (ASUGI), University of Trieste Coordinator of this site? Confirm its status | Trieste | Italy | Recruiting |
| University Medical Center Utrecht Coordinator of this site? Confirm its status | Utrecht | Netherlands | Recruiting |
Related publications
- Definition and Prognosis of Mitral Regurgitation in Transthyretin Amyloid Cardiomyopathy: A Multicenter International Cohort Study.Circulation · 2026 · PMID 42866868
This page is information, not medical advice. Discuss any trial with your doctor.