Clinical trial NCT05884892: Egyptian Hypertrophic Cardiomyopathy Program
Official title: Egyptian Hypertrophic Cardiomyopathy Program
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hypertrophic Cardiomyopathy
Keywords: HCM
HOCM
Hypertrophic Cardiomyopathy
Familial Hypertrophic Cardiomyopathy
Hypertrophic Cardiomyopathy with Genetic Marker
Hypertrophic Obstructive Cardiomyopathy
Lead sponsor: Magdi Yacoub Heart Foundation
Sponsor class: OTHER
First posted: 2023-06-01
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Egyptian patients diagnosed with hypertrophic cardiomyopathy (either obstructive or non-obstructive), and their family members (either apparently healthy or not) who are willing to participate in this registry.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of HCM in Egypt
timeFrame: through study completion, an average of 5 year
measure: Determinants of clinical severity of HCM in Egypt
timeFrame: through study completion, an average of 1 follow-up every year, and an average of 5 follow-ups throughout the study duration
measure: Determinants of cardiac phenotype severity of HCM in Egypt
timeFrame: through study completion, an average of 1 follow-up every year, and an average of 5 follow-ups throughout the study duration
measure: Determinant of genotype severity of HCM in Egypt
timeFrame: through study completion, at least once at the time of inclusion
measure: Study the basic mechanisms responsible for the HCM in Egypt
timeFrame: through study completion, at least once at the time of inclusion, or
Secondary outcomes:
Other outcomes:
Locations:
city: Aswan
country: Egypt
facility: Aswan Heart Centre - Magdi Yacoub Heart Foundation
Study officials:
References: