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Correlation of Pathogenic Variants in the DMD Gene With Cardiac Dysfunction in Male Children, Adolescents, and Young Adults With Dystrophinopathies: A Pilot Study

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

The goal of this observational study is to investigate whether the type, location, and extent of pathogenic variants in the DMD gene are associated with cardiac dysfunction in male children, adolescents, and young adults with dystrophinopathies. The study also evaluates whether cardiac biomarkers and electrocardiographic findings can facilitate the early identification of cardiac involvement. Participants will undergo electrocardiography, blood sampling for cardiac biomarker assessment, and transthoracic echocardiography, with cardiac dysfunction evaluated using ejection fraction (EF) and global longitudinal strain (GLS).

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 2
Maximum Age: 24
Healthy Volunteers: f
View:

• Male sex

• Age between 2 and 24 years at the time of enrollment

• Genetically confirmed dystrophinopathy with a pathogenic or likely pathogenic variant in the DMD gene

• Genetic confirmation based on at least one validated method, including MLPA, NGS, Sanger sequencing, array-CGH, or qPCR

• Written informed consent from parents or legal guardians and, where applicable, consent from the participant

Locations
Other Locations
Greece
AHEPA University Hospital of Thessaloniki
RECRUITING
Thessaloniki
Contact Information
Primary
Ioanna Agathokleous, MD, MSc, PhD(c)
iagatho@auth.gr
+30 2313303534
Time Frame
Start Date: 2026-01-26
Estimated Completion Date: 2028-02
Participants
Target number of participants: 65
Treatments
Male participants with genetically confirmed dystrophinopathies
Male children, adolescents, and young adults aged 2 to 24 years with genetically confirmed dystrophinopathies caused by pathogenic or likely pathogenic variants in the DMD gene.
Sponsors
Leads: Aristotle University Of Thessaloniki
Collaborators: AHEPA University Hospital

This content was sourced from clinicaltrials.gov