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NCT05556369 Clinical Trial

Genetic Characterization of Cardiomyopathies (POLICARDIOMIO2021)

Cardiomyopathies Clinical Trial

Official title:
Genetic Characterization of Cardiomyopathies (POLICARDIOMIO2021)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05556369
Other study ID # 2385
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 1, 2021
Est. completion date September 1, 2026

Study information
Verified date April 2024
Source Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Contact Stefano Carugo, Principal Investigator
Phone +39 0255033579
Email stefano.carugo@policlinico.mi.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Cardiomyopathy refers to a diverse group of myocardial diseases with multiple causes. In 1995, the World Health Organization classified cardiomyopathies into hypertrophic, dilated, restrictive, and mixed type. This classification is based on the pathophysiology of the disease. However, with rapid evolution of molecular genetics in cardiology, the American Heart Association in 2006 has classified cardiomyopathies into two major groups based on predominant organ involvement and etiology; Primary cardiomyopathies are those solely or predominantly confined to heart muscle and are relatively few in number. Secondary cardiomyopathies show pathologic myocardial involvement as part of a large number and variety of generalized systemic (multiorgan) disorders.Current evidence supports the use of genetic testing in clinical practice to improve risk stratification for clinically affected patients and their at-risk relatives for cardiomyopathies.

Recruitment information / eligibility
Status Recruiting
Enrollment 288
Est. completion date September 1, 2026
Est. primary completion date September 1, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Presence of structural cardiomyopathy - First degree relatives for cardiomyopathy Exclusion Criteria: - Age > 80 - Presence of sufficient conditions to explain the clinical condition of cardiomyopathy - Peripartum cardiomyopathy

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Italy Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico Milan Lombardia

Sponsors (1)
Lead Sponsor Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Genetic Characterization To perform a genetic characterization of subjects affected by structural cardiomyopathies with clinical suspicion of genetic pattern 5 years
Secondary Genetic and phenotypic characterization of the first degree relatives To perform a genetic and phenotypic characterization of the first degree relatives of a subject affected by genetic structural cardiomyopathy. 5 years
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