Echocardiographic Characterization of Cardiac Amyloidosis

Echocardiographic Characterization of Cardiac Amyloidosis: an Observational Study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05760287

Acronym

Echo-AMY

Enrollment

255

Registered

2023-03-08

Start date

2022-12-09

Completion date

2031-02-02

Last updated

2026-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Amyloidosis

Keywords

echocardiography, left ventricle

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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
cardiovascular outcomes	24 months	composite endpoint of death and heart failure hospitalization

Secondary

Measure	Time frame	Description
major cardiac arrhythmias	24 months	bradyarrhythmia, new-onset atrial fibrillation, ventricular tachycardia

Countries

Italy

Contacts

CONTACTFrancesca Graziani, MD

francesca.graziani@policlinicogemelli.it00390630154432

CONTACTmaria chiara meucci, MD

mariachiara.meucci@guest.policlinicogemelli.it00390630154432

PRINCIPAL_INVESTIGATORFrancesca Graziani

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Outcome results