Understanding Atrioventricular Regurgitation in ATTR Amyloid Cardiomyopathy
Definition and Prognosis of Atrioventricular Regurgitation in Transthyretin Amyloid Cardiomyopathy - a Prospective International Multicenter Study
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 |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical University of Vienna Academic / other |
| Locations | 8 sites (Graz, Styria and 7 other locations) |
| Trial ID | NCT06836011 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older diagnosed with ATTR-CM who can provide informed consent.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Graz, Styria and 7 other locations
- 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)
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.