ATTR Amyloidosis Wild Type, ATTR Amyloidosis With Cardiomyopathy, ATTR-CM, Mitral Regurgitation, Tricuspid Regurgitation
Conditions
Keywords
ATTR-CM, ATTR amyloidosis, Tricuspid Regurgitation, Mitral Regurgitation
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.
Interventions
None listed
Sponsors
Medical University of Vienna
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality | up to 60 months | Assessment of all-cause mortality in patients with ATTR-CM, stratified by baseline quantitative and semiquantitative measures of mitral and tricuspid regurgitation severity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiovscular mortality | up to 60 months | — |
| Heart Failure Hospitalization | up to 60 months | Time to first heart failure hospitalization Rate of heart failure hospitalizations |
Other
| Measure | Time frame | Description |
|---|---|---|
| Progression of Atrioventricular Regurgitation | At 12 and 24 months follow-up | Change in mitral and tricuspid regurgitation severity over time and its impact on clinical outcomes. |
Countries
Austria, Germany, Italy, Netherlands
Contacts
Primary ContactChristian Nitsche, Priv.-Doz. Dr., PhD
Backup ContactLaurenz Hauptmann, Dr.
Outcome results
None listed