NCT05884892

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
45mo left

Started Jan 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
Jan 2014Jan 2030

Study Start

First participant enrolled

January 1, 2014

Completed
9 years until next milestone

First Submitted

Initial submission to the registry

December 14, 2022

Completed
6 months until next milestone

First Posted

Study publicly available on registry

June 1, 2023

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2030

Last Updated

June 1, 2023

Status Verified

May 1, 2023

Enrollment Period

16 years

First QC Date

December 14, 2022

Last Update Submit

May 23, 2023

Conditions

Keywords

HCMHOCMHypertrophic CardiomyopathyFamilial Hypertrophic CardiomyopathyHypertrophic Cardiomyopathy with Genetic MarkerHypertrophic Obstructive Cardiomyopathy

Outcome Measures

Primary Outcomes (5)

  • Incidence of HCM in Egypt

    per 100,000 population per year

    through study completion, an average of 5 year

  • 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

  • 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

  • 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

  • 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

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • Refusal to consent to participate in the registry program.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aswan Heart Centre - Magdi Yacoub Heart Foundation

Aswān, Egypt

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Our biobank includes: * Blood samples for genetic analysis from all recruited patients and their family members. * Human specimens collected from hypertrophic cardiomyopathy patients after surgical intervention (extended septal myectomy).

MeSH Terms

Conditions

Cardiomyopathy, HypertrophicCardiomyopathy, Hypertrophic, Familial

Condition Hierarchy (Ancestors)

CardiomyopathiesHeart DiseasesCardiovascular DiseasesAortic Stenosis, SubvalvularAortic Valve StenosisAortic Valve DiseaseHeart Valve DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Magdi H Yacoub, FRS OM

CONTACT

Shehab M Anwer, MBBCh., MRes

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2022

First Posted

June 1, 2023

Study Start

January 1, 2014

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 1, 2030

Last Updated

June 1, 2023

Record last verified: 2023-05

Locations