Echocardiographic Characterization of Cardiac Amyloidosis

Recruiting

• Conditions: Cardiac Amyloidosis

• Registration Number: NCT05760287
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-09
• Study First Submitted: 2023-02-27
• Study First Submitted QC: 2023-02-27
• Study First Posted: 2023-03-08
• Status Verified: 2024-11
• Last Update Submitted: 2025-03-14
• Last Update Posted: 2025-03-18
• Primary Completion: 2030-12-02
• Study Completion: 2031-02-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 255

Inclusion Criteria

• 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.

Exclusion Criteria

• missing data
• decline to the study participation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
cardiovascular outcomes	24 months	composite endpoint of death and heart failure hospitalization
changes in echocardiographic parameters (in patients receiving or not specific treatment)	6 months	variation in global longitudinal strain, diastolic parameters and degree of ventricular hypertrophy

Secondary Outcome Measures

Name	Time	Method
major cardiac arrhythmias	24 months	bradyarrhythmia, new-onset atrial fibrillation, ventricular tachycardia

Trial Locations

Locations (1)

Fondazione Policlinico Gemelli IRCCS; 🇮🇹 Roma, RM, Italy