A Multicenter Study on Atrioventricular Regurgitation in Transthyretin Amyloid Cardiomyopathy: Definition, Prevalence, and Prognostic Impact.

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMedical University of Vienna

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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

Time frame
up to 60 months

Secondary outcomes

1

Cardiovscular mortality

Time frame
up to 60 months
2

Heart Failure Hospitalization

Time to first heart failure hospitalization Rate of heart failure hospitalizations

Time frame
up to 60 months

Other outcomes

1

Progression of Atrioventricular Regurgitation

Change in mitral and tricuspid regurgitation severity over time and its impact on clinical outcomes.

Time frame
At 12 and 24 months follow-up

Sponsors and contacts

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