Echocardiographic Characterization of Cardiac Amyloidosis

NCT ID: NCT05760287

Last Updated: 2025-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

255 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-09

Study Completion Date

2031-02-02

Brief Summary

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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

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Conditions

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Cardiac Amyloidosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fondazione Policlinico Gemelli IRCCS

Roma, RM, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Francesca Graziani, MD

Role: CONTACT

00390630154432

maria chiara meucci, MD

Role: CONTACT

00390630154432

Facility Contacts

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francesca graziani, MD

Role: primary

+31 3313957433

maria chiara meucci, MD

Role: backup

+ 31 3313957433

Other Identifiers

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5308

Identifier Type: -

Identifier Source: org_study_id

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