About this trial
This is a mono-center observational ambispective study in which patients with cardiac amyloidosis evaluated at the Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Rome, Italy) will be enrolled.
The primary aim is to investigate echocardiographic findings, particularly using advanced echocardiographic techniques, such as two- and three-dimensional speckle-tracking analysis, that may be helpful in the differential diagnosis between cardiac amyloidosis and other cardiomyopathies with hypertrophic phenotype.
Secondary aims are: 1) to evaluate the reversibility of myocardial damage, assessed by echocardiography, in response to a newly available specific treatment for patients with transthyretin-related cardiac amyloidosis (tafamidis) and its correlation with the clinical response 2) to investigate potential novel echocardiographic predictors of adverse cardiovascular outcomes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
patients with cardiac amyloidosis, defined according to the recommendations provided by the working group of the european society of cardiology, with clinical, electrocardiographic ed echocardiographic data and with at least one follow-up visit.
Disqualifiers
missing data
decline to the study participation
Trial population
In the retrospective phase, patients with cardiac amyloidosis evaluated at the Fondazione Policlinico Agostino Gemelli between January 2020 and November 2022 will be enrolled. In the prospective phase, patients with the same features evaluated between December 2022 and December 2028.
Trial design
Cohort
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
changes in echocardiographic parameters (in patients receiving or not specific treatment)
variation in global longitudinal strain, diastolic parameters and degree of ventricular hypertrophy
cardiovascular outcomes
composite endpoint of death and heart failure hospitalization
Secondary outcomes
major cardiac arrhythmias
bradyarrhythmia, new-onset atrial fibrillation, ventricular tachycardia
Sponsors and contacts
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