NCT06836011 A Multicenter Study on Atrioventricular Regurgitation in Transthyretin Amyloid Cardiomyopathy: Definition, Prevalence, and Prognostic Impact.
| NCT ID | NCT06836011 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical University of Vienna |
| Condition | ATTR Amyloidosis With Cardiomyopathy |
| Study Type | OBSERVATIONAL |
| Enrollment | 600 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 600 participants in total. It began in 2025-01-01 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06836011 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying ATTR Amyloidosis With Cardiomyopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06836011 currently recruiting?
Yes, NCT06836011 is actively recruiting participants. Contact the research team at christian.nitsche@meduniwien.ac.at for enrollment information.
Where is the NCT06836011 trial being conducted?
This trial is being conducted at Graz, Austria, Vienna, Austria, Munich, Germany, Frankfurt am Main, Germany and 4 additional locations.
Who is sponsoring the NCT06836011 clinical trial?
NCT06836011 is sponsored by Medical University of Vienna. The trial plans to enroll 600 participants.