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NCT Number: NCT05884892

Egyptian Hypertrophic Cardiomyopathy Program

Egyptian HCM program aims at defining incidence, severity, phenotype, genotype and determinants of the disease in Egypt, and providing state-of-the-art treatment strategies including medical, surgical and interventional procedures which are patient- and disease-specific.

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Key information

Conditions

Hypertrophic Cardiomyopathy Aortic Stenosis, Subvalvular Aortic Valve Disease Aortic Valve Stenosis Cardiomyopathies Cardiomyopathy, Hypertrophic Cardiomyopathy, Hypertrophic, Familial Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Heart Diseases Heart Valve Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

This project aims to:

  • Define incidence, severity, phenotype, genotype and determinants of the disease in Egypt.
  • Characterise the phenotype and genotype of several large cohorts with inherited muscle disease and their relatives.
  • Provide state-of-the-art treatment strategies including medical, surgical and interventional procedures which are patient- and disease-specific.
  • Study the basic mechanisms responsible for the different phenotypes at a molecular and cellular level including genotype-phenotype correlation.
  • Provide a special focus for studying patients who are genotype positive and phenotype negative which we believe could yield critical data regarding the evolution of the disease.
  • Develop sophisticated laboratory studies for single cell electrophysiology and immunocytochemistry and others focusing on the explanted human material from the surgical program.
  • Define the role of microvascular coronary artery in the development and progression of the disease.
  • Training Egyptian cardiologists, cardiac surgeons and scientists on state-of-the-art diagnosis and management of heart muscle disease including the latest developments in imaging, novel surgical techniques, coronary physiology, next generation sequencing, bioinformatics and cellular electrophysiology.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients diagnosed with hypertrophic cardiomyopathy (index patients) who are willing and consented to participate in the registry.
  • All family members of index patients who are willing and consented to participate in the registry.

Exclusion criteria

  • Refusal to consent to participate in the registry program.

Treatment and study plan

Primary outcomes

  1. Incidence of HCM in Egypt

    Time frame: through study completion, an average of 5 year

    per 100,000 population per year

  2. Determinants of clinical severity of HCM in Egypt

    Time frame: through study completion, an average of 1 follow-up every year, and an average of 5 follow-ups throughout the study duration

    Several indicators describing the clinical symptoms and signs

  3. Determinants of cardiac phenotype severity of HCM in Egypt

    Time frame: through study completion, an average of 1 follow-up every year, and an average of 5 follow-ups throughout the study duration

    Several indicators describing the cardiac phenotype using multimodality imaging

  4. Determinant of genotype severity of HCM in Egypt

    Time frame: through study completion, at least once at the time of inclusion

    To identify and report the genetic profile of HCM in Egypt.

  5. Study the basic mechanisms responsible for the HCM in Egypt

    Time frame: through study completion, at least once at the time of inclusion, or

    To study different phenotypes at a molecular and cellular level including genotype-phenotype correlation.

Study contacts

Contact information is provided by the study sponsor or research team.

Magdi H Yacoub, FRS OM

CONTACT

[email protected]

Shehab M Anwer, MBBCh., MRes

CONTACT

[email protected]

+41788816333

Sponsors and collaborators

Lead sponsor

Magdi Yacoub Heart Foundation

Other

Registry information

Important dates

Study start
2014
Primary completion
2030
Study completion
2030
First posted
Jun 1, 2023
Registry last updated
Jun 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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