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.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 600 (estimated) |
| Sponsor | Medical University of Vienna Academic / other |
| Locations | 8 sites (Graz, Styria and 7 other locations) |
| Status | Recruiting |
| Started | January 1, 2025 |
| Main results expected | December 31, 2025 |
| Study ends | December 31, 2026 |
| Registry record updated | February 19, 2025 |
| Trial ID | NCT06836011 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
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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
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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
- Study coordinator: Christian Nitsche, Priv.-Doz. Dr., PhD
- Email: christian.nitsche@meduniwien.ac.at
- Phone: +4314040048590
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Compare leadless and left bundle branch pacemakers for heart and valve function
This study tests whether leadless pacemakers or left bundle branch area pacing better preserve heart and tricuspid valve function in adults needing a pacemaker.
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Posterior Mitral Leaflet Replacement to Reduce Mitral Regurgitation
This early feasibility trial tests the MR-ace Implant and Delivery System to see if it can reduce symptoms and leaks in people with moderate-to-severe functional mitral regurgitation.
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TriClip for treating tricuspid regurgitation in Japan
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.