Egyptian Hypertrophic Cardiomyopathy Program

Sponsor

Magdi Yacoub Heart Foundation (Other)

Overall Status

Recruiting

CT.gov ID

NCT05884892

Collaborator

(none)

2,000

Enrollment

Location

192

Anticipated Duration (Months)

10.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertrophic Cardiomyopathy

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

2000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Egyptian Hypertrophic Cardiomyopathy Program

Actual Study Start Date :

Jan 1, 2014

Anticipated Primary Completion Date :

Jan 1, 2030

Anticipated Study Completion Date :

Jan 1, 2030

Outcome Measures

Primary Outcome Measures

Incidence of HCM in Egypt [through study completion, an average of 5 year]
per 100,000 population per year
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
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.