About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Severe aortic valve disease requiring intervention
Inability to provide informed consent or participate in study follow-up
Trial population
This observational study will include patients diagnosed with transthyretin amyloid cardiomyopathy (ATTR-CM) from international specialized cardiac amyloidosis referral centers. The study population will encompass both wild-type and hereditary ATTR-CM patients, ensuring representation of diverse disease phenotypes. Data collection will be standardized across centers, with echocardiographic assessments performed in accordance with the dedicated study protocol. The inclusion of multiple international centers will enhance the generalizability of findings across different healthcare systems and patient populations.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
All-cause mortality
Assessment of all-cause mortality in patients with ATTR-CM, stratified by baseline quantitative and semiquantitative measures of mitral and tricuspid regurgitation severity
Secondary outcomes
Cardiovscular mortality
Heart Failure Hospitalization
Time to first heart failure hospitalization Rate of heart failure hospitalizations
Other outcomes
Progression of Atrioventricular Regurgitation
Change in mitral and tricuspid regurgitation severity over time and its impact on clinical outcomes.
Sponsors and contacts
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