Studying heart valve leakage in people with transthyretin amyloid heart disease
Observes how valve leakage in the heart affects people with transthyretin amyloid cardiomyopathy.
Key facts
- Who runs it
- Medical University of Vienna
- Where
- Frankfurt am Main and Munich, GermanySee the 2 sitesAlso in 3 other countries, 6 sites
- Trial code
- Registry title
- A Multicenter Study on Atrioventricular Regurgitation in Transthyretin Amyloid Cardiomyopathy: Definition, Prevalence, and Prognostic Impact.
- Status
- Recruiting
- People taking part
- 600 people, planned
- Started
- 1 Jan 2025
- Expected to end
- 31 Dec 2026
- Type of study
- Observational
- Record updated
- 19 February 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults diagnosed with transthyretin amyloid cardiomyopathy (ATTR-CM) who had a full heart ultrasound within 6 months of diagnosis. It studies leaking heart valves.
- Age
- 18 years or older
- Sex
- All sexes
- Disease stage
- Diagnosis of ATTR-CM according to current diagnostic criteria
Main reasons for not taking part
- Severe aortic valve disease that needs a procedure
- Cannot give informed consent or take part in follow-up
The registry criteria, word for word
Show all 6 criteriaShow less
Who can take part
- 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
Who cannot take part
- Severe aortic valve disease requiring intervention
- Inability to provide informed consent or participate in study follow-up
Where in Germany
Also in 3 other countries, 6 sites
- Department of Cardiology, University Hospital Frankfurt, Goethe UniversityFrankfurt am Main, GermanyContact: Maria Papathanasiou, Priv.-Doz. Dr. med.Taking people
- Medizinische Klinik und Poliklinik I, Klinikum der Universitaet Muenchen, Ludwig-Maximilians-UniversityMunich, GermanyContact: Stephanie Bieber, Dr. med.Taking people
About the trial
What the trial wants to find out
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.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Definition and Prognosis of Atrioventricular Regurgitation in Transthyretin Amyloid Cardiomyopathy - a Prospective International Multicenter Study
- Plain-language title
- Studying heart valve leakage in people with transthyretin amyloid heart diseaseGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Publications
- Record updated
- 19 February 2025