Ignite Creation Date:
2025-12-24 @ 3:43 PM
Ignite Modification Date:
2026-01-03 @ 9:22 PM
Study NCT ID:
NCT05884892
Status:
RECRUITING
Last Update Posted:
2023-06-01
First Post:
2022-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Egyptian Hypertrophic Cardiomyopathy Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002312', 'term': 'Cardiomyopathy, Hypertrophic'}, {'id': 'D024741', 'term': 'Cardiomyopathy, Hypertrophic, Familial'}], 'ancestors': [{'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001020', 'term': 'Aortic Stenosis, Subvalvular'}, {'id': 'D001024', 'term': 'Aortic Valve Stenosis'}, {'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Our biobank includes:\n\n* Blood samples for genetic analysis from all recruited patients and their family members.\n* Human specimens collected from hypertrophic cardiomyopathy patients after surgical intervention (extended septal myectomy).'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2030-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-23', 'studyFirstSubmitDate': '2022-12-14', 'studyFirstSubmitQcDate': '2023-05-23', 'lastUpdatePostDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of HCM in Egypt', 'timeFrame': 'through study completion, an average of 5 year', 'description': 'per 100,000 population per 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', 'description': 'Several indicators describing the clinical symptoms and signs'}, {'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', 'description': 'Several indicators describing the cardiac phenotype using multimodality imaging'}, {'measure': 'Determinant of genotype severity of HCM in Egypt', 'timeFrame': 'through study completion, at least once at the time of inclusion', 'description': 'To identify and report the genetic profile of HCM in Egypt.'}, {'measure': 'Study the basic mechanisms responsible for the HCM in Egypt', 'timeFrame': 'through study completion, at least once at the time of inclusion, or', 'description': 'To study different phenotypes at a molecular and cellular level including genotype-phenotype correlation.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HCM', 'HOCM', 'Hypertrophic Cardiomyopathy', 'Familial Hypertrophic Cardiomyopathy', 'Hypertrophic Cardiomyopathy with Genetic Marker', 'Hypertrophic Obstructive Cardiomyopathy'], 'conditions': ['Hypertrophic Cardiomyopathy']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'This project aims to:\n\n* Define incidence, severity, phenotype, genotype and determinants of the disease in Egypt.\n* Characterise the phenotype and genotype of several large cohorts with inherited muscle disease and their relatives.\n* Provide state-of-the-art treatment strategies including medical, surgical and interventional procedures which are patient- and disease-specific.\n* Study the basic mechanisms responsible for the different phenotypes at a molecular and cellular level including genotype-phenotype correlation.\n* 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.\n* Develop sophisticated laboratory studies for single cell electrophysiology and immunocytochemistry and others focusing on the explanted human material from the surgical program.\n* Define the role of microvascular coronary artery in the development and progression of the disease.\n* 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients diagnosed with hypertrophic cardiomyopathy (index patients) who are willing and consented to participate in the registry.\n* All family members of index patients who are willing and consented to participate in the registry.\n\nExclusion Criteria:\n\n* Refusal to consent to participate in the registry program.'}, 'identificationModule': {'nctId': 'NCT05884892', 'briefTitle': 'Egyptian Hypertrophic Cardiomyopathy Program', 'organization': {'class': 'OTHER', 'fullName': 'Magdi Yacoub Heart Foundation'}, 'officialTitle': 'Egyptian Hypertrophic Cardiomyopathy Program', 'orgStudyIdInfo': {'id': 'AHC-HCM'}}, 'contactsLocationsModule': {'locations': [{'city': 'Aswān', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ahmed M ElGuindy, MD, MRCP', 'role': 'CONTACT', 'email': 'ahmed_elguindy@hotmail.com', 'phone': '+201001615151'}, {'name': 'Shehab M Anwer, MBBCh, MRes, PhD', 'role': 'CONTACT', 'email': 'shehabanwer@gmail.com', 'phone': '+41788816333'}, {'name': 'Magdi H Yacoub, OM FRS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Aswan Heart Centre - Magdi Yacoub Heart Foundation', 'geoPoint': {'lat': 24.09082, 'lon': 32.89942}}], 'centralContacts': [{'name': 'Magdi H Yacoub, FRS OM', 'role': 'CONTACT', 'email': 'm.yacoub@imperial.ac.uk'}, {'name': 'Shehab M Anwer, MBBCh., MRes', 'role': 'CONTACT', 'email': 'shehabanwer@gmail.com', 'phone': '+41788816333'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Magdi Yacoub Heart Foundation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}