Echocardiographic Characterization of Cardiac Amyloidosis

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

changes in echocardiographic parameters (in patients receiving or not specific treatment)

variation in global longitudinal strain, diastolic parameters and degree of ventricular hypertrophy

Time frame
6 months
2

cardiovascular outcomes

composite endpoint of death and heart failure hospitalization

Time frame
24 months

Secondary outcomes

1

major cardiac arrhythmias

bradyarrhythmia, new-onset atrial fibrillation, ventricular tachycardia

Time frame
24 months

Other outcomes

Sponsors and contacts

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