Echocardiographic Characterization of Cardiac Amyloidosis: an Observational Study

Cardiac Amyloidosis Clinical Trial

— Echo-AMY  

Official title:

Echocardiographic Characterization of Cardiac Amyloidosis: an Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05760287
• Other study ID #: 5308
• Status: Recruiting
• Start date: December 9, 2022
• Est. completion date: February 2, 2031

Study information

• Verified date: February 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Francesca Graziani, MD
• Phone: 00390630154432
• Email: francesca.graziani[@]policlinicogemelli.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a mono-center observational ambispective study in which patients with cardiac amyloidosis evaluated at our institution 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 255
• Est. completion date: February 2, 2031
• Est. primary completion date: December 2, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients with cardiac amyloidosis, defined according to the recommendation provided by the working group of the european society of cardiology, with clinical, electrocardiographic ed echocardiographic data at our institution and with at least one follow-up visit.

Exclusion Criteria:

• missing data

• decline to the study participation

Related Conditions & MeSH terms

• Amyloidosis
• Cardiac Amyloidosis

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Gemelli IRCCS	Roma	RM

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	cardiovascular outcomes	composite endpoint of death and heart failure hospitalization	24 months
Secondary	major cardiac arrhythmias	bradyarrhythmia, new-onset atrial fibrillation, ventricular tachycardia	24 months