Hypertrophic CardiomyopathyNCT05884892
Egyptian Hypertrophic Cardiomyopathy Program
An observational study of Hypertrophic Cardiomyopathy, run by Magdi Yacoub Heart Foundation at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hypertrophic Cardiomyopathy
- How many people
- 2,000 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2014to 1 Jan 2030
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Refusal to consent to participate in the registry program.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Magdi H Yacoub, FRS OM contact
Egypt1 site, 1 recruiting
- Recruiting
Aswan Heart Centre - Magdi Yacoub Heart Foundation
Aswān
Ahmed M ElGuindy, MD, MRCP, +201001615151, ahmed_elguindy@hotmail.com
Shehab M Anwer, MBBCh, MRes, PhD, +41788816333, shehabanwer@gmail.com
About this study
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.
Read the 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.
- Conditions
- Hypertrophic Cardiomyopathy
- Keywords
- HCM, HOCM, Hypertrophic Cardiomyopathy, Familial Hypertrophic Cardiomyopathy, Hypertrophic Cardiomyopathy with Genetic Marker, Hypertrophic Obstructive Cardiomyopathy
- Medical subject headings
- Cardiomyopathy, Hypertrophic, Cardiomyopathy, Hypertrophic, Familial
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of HCM in Egypt
per 100,000 population per year
Measured: through study completion, an average of 5 year
Determinants of clinical severity of HCM in Egypt
Several indicators describing the clinical symptoms and signs
Measured: 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
Measured: 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.
Measured: 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.
Measured: through study completion, at least once at the time of inclusion, or
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start1 Jan 2014
- Primary completion1 Jan 2030 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophic CardiomyopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Magdi Yacoub Heart Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05884892
- Sponsor's protocol ID
- AHC-HCM
- Status last verified
- May 2023
- First submitted
- 14 Dec 2022
- Last updated
- 1 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Egyptian Hypertrophic Cardiomyopathy Program
- ClinicalTrials.gov ID
- NCT05884892
- Acronym / sponsor ID
- AHC-HCM
- Conditions
- Hypertrophic Cardiomyopathy
- Keywords
- HCM, HOCM, Hypertrophic Cardiomyopathy, Familial Hypertrophic Cardiomyopathy, Hypertrophic Cardiomyopathy with Genetic Marker, Hypertrophic Obstructive Cardiomyopathy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Magdi Yacoub Heart FoundationUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 1 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Refusal to consent to participate in the registry program.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of HCM in Egypt
Time frame: through study completion, an average of 5 year
per 100,000 population per 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
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
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
- Individual participant dataSharing planned: Undecided
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A Study to Learn More About How Well Aficamten Works in Japanese Participants With Symptomatic Obstructive Hypertrophic Cardiomyopathy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Magdi H Yacoub, FRS OM contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertrophic Cardiomyopathy, run by Magdi Yacoub Heart Foundation at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Magdi H Yacoub, FRS OM (m.yacoub@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of HCM in Egypt (time frame: through study completion, an average of 5 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2023.