Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 7:24 AM
Study NCT ID:
NCT07380893
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-02
First Post:
2025-12-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Left Ventricular Hypertrophy in CKD Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017379', 'term': 'Hypertrophy, Left Ventricular'}], 'ancestors': [{'id': 'D006332', 'term': 'Cardiomegaly'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006984', 'term': 'Hypertrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-07-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-24', 'studyFirstSubmitDate': '2025-12-30', 'studyFirstSubmitQcDate': '2026-01-24', 'lastUpdatePostDateStruct': {'date': '2026-02-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in LVMI following erythropoietin therapy in anemic CKD patients.', 'timeFrame': '- baseline transthoracic echocardiography will be performed for all group study.'}], 'secondaryOutcomes': [{'measure': 'Association between hemoglobin level and LVMI.', 'timeFrame': '6 months of erythropoitin therapy , transthoracic echocardiography will be performed for all group study.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Left Ventricular Hypertrophy']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to determine the prevalence of left ventricular hypertrophy among patients with chronic kidney disease at Sohag University Hospital and assess the effect of erythropoietin therapy on left ventricular mass and geometry in anemic CKD patients.\n\nThe main question it aims to answer is:\n\nDoes erythropoietin therapy mitigate or even reverse LVH and improve cardiac geometry ?', 'detailedDescription': 'The prevalence of LVH in CKD patients has been reported to range from 40% to 75%, depending on disease stage, blood pressure control, and diagnostic methodology. LVH typically develops early and worsens with CKD progression, reflecting the close interplay between renal dysfunction and cardiac remodeling.\n\nAnemia is a prominent non-hemodynamic contributor to LVH in CKD. Reduced erythropoietin (EPO) production by the damaged kidneys, together with iron deficiency and chronic inflammation, leads to decreased oxygen delivery, compensatory cardiac output elevation, and subsequent ventricular hypertrophy.\n\nGiven the strong association between CKD, anemia, and cardiovascular remodeling, investigating the prevalence of LVH and the effect of erythropoietin therapy on left ventricular mass among CKD patients can provide critical insights into optimizing cardiovascular risk management in this high-risk group.\n\nthis study will be conducted to :\n\n1. To determine the prevalence of left ventricular hypertrophy among patients with chronic kidney disease at Sohag University Hospital.\n2. To assess the effect of erythropoietin therapy on left ventricular mass and geometry in anemic CKD patients.\n\nA total of 100 CKD patients will be included.\n\n* Phase I : All CKD patients will undergo echocardiographic evaluation to determine the prevalence of LVH.\n* Phase II : Among anemic CKD patients with LVH receiving erythropoietin therapy , will be followed for 6 months'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'study population is adults age (18-75)years, diagnosed with CKD stage 3-5 .', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults (≥18 years) diagnosed with CKD stages 3-5.\n* Stable clinical condition for ≥3 months.\n* Anemia (Hb \\<10 g/dL) for cohort phase.\n* Willingness to participate and provide informed consent.\n\nExclusion Criteria:\n\n* Valvular or ischemic heart disease.\n* Uncontrolled hypertension (BP \\>180/110 mmHg).\n* Acute coronary syndrome or decompensated heart failure in the past 3 months.\n* Malignancy or active infection'}, 'identificationModule': {'nctId': 'NCT07380893', 'briefTitle': 'Left Ventricular Hypertrophy in CKD Patients', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Prevalence of Left Ventricular Hypertrophy (LVH) in CKD Patients and Effect of Erythropoietin Therapy', 'orgStudyIdInfo': {'id': 'Soh-Med--25-11-7MS'}}, 'armsInterventionsModule': {'interventions': [{'name': 'transthoracic echocardiography', 'type': 'RADIATION', 'description': 'Standard transthoracic echocardiography will be performed for all participants, measuring:\n\n* Left ventricular end-diastolic diameter (LVEDD)\n* Interventricular septal thickness (IVSD)\n* Posterior wall thickness (PWD)\n* Left ventricular mass (LVM)\n* Left ventricular mass index (LVMI = LVM/body surface area)'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'khaled M Mohamedein, MBCHB', 'role': 'CONTACT', 'email': 'drkhaledmmm1984@gmail.com', 'phone': '+201507290373'}, {'name': 'Marwa Z Elsayed, MD', 'role': 'CONTACT', 'phone': '+201007100970'}], 'overallOfficials': [{'name': 'Amal Kh Ahmed, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Sohag university- faculty of medicine - internal medicine department'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident of internal medicine', 'investigatorFullName': 'Khaled Mohamed Mohamedin', 'investigatorAffiliation': 'Sohag University'}}}}