Egyptian Hypertrophic Cardiomyopathy Program

Recruiting

• Conditions: Hypertrophic Cardiomyopathy

• Registration Number: NCT05884892
• Lead Sponsor: Magdi Yacoub Heart Foundation

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2014-01-01
• Study First Submitted: 2022-12-14
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-23
• Last Update Submitted: 2023-05-23
• Study First Posted: 2023-06-01
• Last Update Posted: 2023-06-01
• Primary Completion: 2030-01-01
• Study Completion: 2030-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Study the basic mechanisms responsible for the HCM in Egypt	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.
Determinants of clinical severity of HCM in Egypt	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
Determinants of cardiac phenotype severity of HCM in Egypt	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
Incidence of HCM in Egypt	through study completion, an average of 5 year	per 100,000 population per year
Determinant of genotype severity of HCM in Egypt	through study completion, at least once at the time of inclusion	To identify and report the genetic profile of HCM in Egypt.

Trial Locations

Locations (1)

Aswan Heart Centre - Magdi Yacoub Heart Foundation; 🇪🇬 Aswan, Egypt