Egyptian Hypertrophic Cardiomyopathy Program

Hypertrophic Cardiomyopathy Clinical Trial

Official title:

Egyptian Hypertrophic Cardiomyopathy Program

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05884892
• Other study ID #: AHC-HCM
• Status: Recruiting
• Start date: January 1, 2014
• Est. completion date: January 1, 2030

Study information

• Verified date: May 2023
• Source: Magdi Yacoub Heart Foundation
• Contact: Magdi H Yacoub, FRS OM
• Email: m.yacoub[@]imperial.ac.uk
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: January 1, 2030
• Est. primary completion date: January 1, 2030
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Hypertrophic
• Hypertrophic Cardiomyopathy
• Hypertrophy

Locations

Country	Name	City	State
Egypt	Aswan Heart Centre - Magdi Yacoub Heart Foundation	Aswan

Sponsors (1)

Lead Sponsor	Collaborator
Magdi Yacoub Heart Foundation

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of HCM in Egypt	per 100,000 population per year	through study completion, an average of 5 year
Primary	Determinants of clinical severity of HCM in Egypt	Several indicators describing the clinical symptoms and signs	through study completion, an average of 1 follow-up every year, and an average of 5 follow-ups throughout the study duration
Primary	Determinants of cardiac phenotype severity of HCM in Egypt	Several indicators describing the cardiac phenotype using multimodality imaging	through study completion, an average of 1 follow-up every year, and an average of 5 follow-ups throughout the study duration
Primary	Determinant of genotype severity of HCM in Egypt	To identify and report the genetic profile of HCM in Egypt.	through study completion, at least once at the time of inclusion
Primary	Study the basic mechanisms responsible for the HCM in Egypt	To study different phenotypes at a molecular and cellular level including genotype-phenotype correlation.	through study completion, at least once at the time of inclusion, or