Actively Recruiting

Age: 2Years - 24Years
MALE
NCT07515235

DMD Gene Variants and Cardiac Dysfunction in Young Males With Dystrophinopathies

Led by Aristotle University Of Thessaloniki · Updated on 2026-04-07

65

Participants Needed

1

Research Sites

105 weeks

Total Duration

On this page

Sponsors

A

Aristotle University Of Thessaloniki

Lead Sponsor

A

AHEPA University Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

DMD Gene Variants and Cardiac Dysfunction in Young Males With Dystrophinopathies

Who Can Participate

Age: 2Years - 24Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • No genetically confirmed diagnosis of dystrophinopathy, including diagnosis based only on muscle biopsy without molecular confirmation
  • Absence of a confirmed pathogenic variant in the DMD gene, unless repeat genetic testing confirms it
  • Presence of congenital heart disease or other genetic disorders causing primary cardiomyopathy
  • Presence of other neuromuscular disorders
  • Female carriers, both manifesting and asymptomatic
  • Comorbidities that may independently affect cardiac function, such as severe arterial hypertension, diabetes mellitus, or chronic kidney disease

AI-Screening

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Trial Site Locations

Total: 1 location

1

AHEPA University Hospital of Thessaloniki

Thessaloniki, Greece

Actively Recruiting

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Research Team

I

Ioanna Agathokleous, MD, MSc, PhD(c)

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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