Echocardiographic Characterization of Cardiac Amyloidosis

NCT05760287 | Recruiting

• 1 other identifier: 5308
• Study Type: observational
• Target: 255
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Amyloidosis

Keywords

echocardiography; left ventricle

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• major cardiac arrhythmias

  24 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• missing data
• decline to the study participation

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Gemelli IRCCS

Roma, RM, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Amyloid Neuropathies, Familial

Condition Hierarchy (Ancestors)

Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Nervous System Diseases; Amyloid Neuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Amyloidosis, Familial; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases; Amyloidosis; Proteostasis Deficiencies

Central Study Contacts

Francesca Graziani, MD

CONTACT

00390630154432; francesca.graziani@policlinicogemelli.it

maria chiara meucci, MD

CONTACT

00390630154432; mariachiara.meucci@guest.policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: March 8, 2023
• Study Start: December 9, 2022
• Primary Completion (Estimated): December 2, 2030
• Study Completion (Estimated): February 2, 2031
• Last Updated: March 18, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)