Ignite Creation Date:
2025-12-24 @ 12:15 PM
Ignite Modification Date:
2026-02-25 @ 11:06 PM
Study NCT ID:
NCT06485661
Status:
RECRUITING
Last Update Posted:
2024-07-16
First Post:
2024-06-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Captopril on GLS in Duchenne Myodystrophy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002216', 'term': 'Captopril'}], 'ancestors': [{'id': 'D011392', 'term': 'Proline'}, {'id': 'D007098', 'term': 'Imino Acids'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-13', 'studyFirstSubmitDate': '2024-06-27', 'studyFirstSubmitQcDate': '2024-06-27', 'lastUpdatePostDateStruct': {'date': '2024-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The impaired global longitudinal strain will change in echo in the number of participants with duchenne myodystrophy', 'timeFrame': '6 months', 'description': 'Impaired Global longitudinal strain will be changed in echo after 6 months of treatment with Captopril in patients with duchenne myodystrophy'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Effect of Drug']}, 'descriptionModule': {'briefSummary': 'To outline the intermediate term effect of prescribing Captopril as an add on therapy on Left ventricular functions as measured by Global longitudinal strain in patients with Duchenne myodystrophy (DMD)', 'detailedDescription': 'ACEI slowing down the onset and the progression of dystrophinopathic cardiomyopathy.\n\nTo outline the intermediate term effect of prescribing Captopril as an add on therapy on Left ventricular functions as measured by Global longitudinal strain in patients with Duchenne myodystrophy (DMD'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Genetically confirmed Duchenne myodystrophy (DMD) patients with abnormal GLS \\< -18% with minimum age of 6 years old.\n\nExclusion Criteria:\n\n* Any patient who refuses to sign an informed consent.\n* Contraindication to ACEI: hypersensitivity - renal impairment - bilateral renal artery stenosis - aortic valve stenosis - hyperkalemia - hypotension.\n* Reduced ejection fraction below 50%.'}, 'identificationModule': {'nctId': 'NCT06485661', 'briefTitle': 'Effect of Captopril on GLS in Duchenne Myodystrophy', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Intermediate Term Effect of Captopril on Left Ventricle Global Longitudinal Strain in Patients With Duchenne Myodystrophy', 'orgStudyIdInfo': {'id': 'MS180/2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Duchenne patients subjected to captopril', 'interventionNames': ['Drug: Captopril Tablets']}], 'interventions': [{'name': 'Captopril Tablets', 'type': 'DRUG', 'description': 'Patients will be given captopril to see effect on global longitudinal strain', 'armGroupLabels': ['Duchenne patients subjected to captopril']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Fatma Ebeid, MD', 'role': 'CONTACT', 'email': 'dr.fatma_ebeid@yahoo.com', 'phone': '00201095569596'}, {'name': 'Sandra M Mina', 'role': 'CONTACT', 'email': 'sandramourad922@yahoo.com', 'phone': '01060781869'}, {'name': 'Mona M Rayan, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ain Shams university', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Fatma Ebeid, MD', 'role': 'CONTACT', 'email': 'dr.fatma_ebeid@yahoo.com', 'phone': '00201095569596'}, {'name': 'Sandra M Mina', 'role': 'CONTACT', 'email': 'sandramourad922@yahoo.com', 'phone': '01060781869'}], 'overallOfficials': [{'name': 'Mona Mostafa Rayan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor of cardiology -Ain Shams university'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}