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Recruiting NCT05556369

Genetic Characterization of Cardiomyopathies (POLICARDIOMIO2021)

Observational Cardiomyopathies

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Cardiomyopathies. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Primary outcome measures

  • Genetic Characterization [Time frame: 5 years]
Secondary outcome measures (1)
  • Genetic and phenotypic characterization of the first degree relatives [Time frame: 5 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico — Milan

Identifiers

NCT: NCT05556369 · 2385

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗