Echocardiographic Characterization of Cardiac Amyloidosis (Echo-AMY)

Echocardiographic Characterization of Cardiac Amyloidosis: an Observational Study

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiac Amyloidosis

• Study Type: Observational
• Enrollment (Estimated): 255

Contacts and Locations

• Study Contact: Name: Francesca Graziani, MD; Phone Number: 00390630154432; Email: francesca.graziani@policlinicogemelli.it
• Study Contact Backup: Name: maria chiara meucci, MD; Phone Number: 00390630154432; Email: mariachiara.meucci@guest.policlinicogemelli.it

Study Locations

• Italy
  • RM
    • Roma, RM, Italy, 00168
      • Recruiting
      • Fondazione Policlinico Gemelli IRCCS
      • Contact: francesca graziani, MD; Phone Number: +31 3313957433; Email: francesca.graziani@policlinicogemelli.it
      • Contact: maria chiara meucci, MD; Phone Number: + 31 3313957433; Email: mariachiara.meucci@guest.policlinicogemelli.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2022
• Primary Completion (Estimated): December 2, 2030
• Study Completion (Estimated): February 2, 2031

Study Registration Dates

• First Submitted: February 27, 2023
• First Submitted That Met QC Criteria: February 27, 2023
• First Posted (Actual): March 8, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 14, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: echocardiography; left ventricle
• Additional Relevant MeSH Terms: Metabolic Diseases; Proteostasis Deficiencies; Amyloidosis
• Other Study ID Numbers: 5308

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No