Egyptian Hypertrophic Cardiomyopathy Program

May 23, 2023 updated by: Magdi Yacoub Heart Foundation
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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Aswan, Egypt
        • Recruiting
        • Aswan Heart Centre - Magdi Yacoub Heart Foundation
        • Contact:
        • Principal Investigator:
          • Magdi H Yacoub, OM FRS
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of HCM in Egypt
Time Frame: through study completion, an average of 5 year
per 100,000 population per year
through study completion, an average of 5 year
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
through study completion, an average of 1 follow-up every year, and an average of 5 follow-ups throughout the study duration
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
through study completion, an average of 1 follow-up every year, and an average of 5 follow-ups throughout the study duration
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.
through study completion, at least once at the time of inclusion
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.
through study completion, at least once at the time of inclusion, or

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Magdi Yacoub Heart Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2014

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 1, 2030

Study Registration Dates

First Submitted

December 14, 2022

First Submitted That Met QC Criteria

May 23, 2023

First Posted (Actual)

June 1, 2023

Study Record Updates

Last Update Posted (Actual)

June 1, 2023

Last Update Submitted That Met QC Criteria

May 23, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AHC-HCM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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