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NCT02432092 Clinical Trial

Pediatric Cardiomyopathy Mutation Analysis

Cardiomyopathies Clinical Trial

Official title:
Pediatric Cardiomyopathy Mutation Analysis

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02432092
Other study ID # 1403919054
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 2014
Est. completion date December 31, 2030

Study information
Verified date February 2024
Source Indiana University
Contact Lindsey Helvaty, BS, BA
Phone (317) 278-3020
Email lhelvaty@iu.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The goal of this protocol is to obtain information from individuals with cardiomyopathy and from their families in order to elucidate the molecular genetics of this disorder. This will provide the basis for future genetic counseling as well as contribute to elucidating the biology of normal and abnormal cardiac function.

Description:

Cardiomyopathy is a genetically heterogeneous heart muscle disorder that results in ventricular dysfunction. While significant progress has been made in identifying the genetic basis of cardiomyopathy in adults, molecular diagnosis in children has proven more challenging and current algorithms do not incorporate mutation analysis in the clinical protocol. However, recent studies indicate that cardiomyopathy outcomes in children are origin specific, highlighting the importance of precise diagnosis. The goal of this study is to identify the genetic causes of pediatric cardiomyopathy. Rapid, comprehensive and cost-effective detection of genetic causes of cardiomyopathy will aid management and development of novel treatment strategies.

Recruitment information / eligibility
Status Recruiting
Enrollment 300
Est. completion date December 31, 2030
Est. primary completion date December 31, 2030
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Subjects with cardiomyopathy - Family members of subjects with cardiomyopathy Exclusion Criteria: - Subjects without cardiomyopathy - Family members of subjects without cardiomyopathy

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States IU School of Medicine Indianapolis Indiana

Sponsors (2)
Lead Sponsor Collaborator
Indiana University American Heart Association

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Elucidate the molecular genetics of cardiomyopathy 7 years
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