- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07380893
Left Ventricular Hypertrophy in CKD Patients
Prevalence of Left Ventricular Hypertrophy (LVH) in CKD Patients and Effect of Erythropoietin Therapy
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.
The main question it aims to answer is:
Does erythropoietin therapy mitigate or even reverse LVH and improve cardiac geometry ?
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Anemia 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.
Given 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.
this study will be conducted to :
- To determine the prevalence of left ventricular hypertrophy among patients with chronic kidney disease at Sohag University Hospital.
- To assess the effect of erythropoietin therapy on left ventricular mass and geometry in anemic CKD patients.
A total of 100 CKD patients will be included.
- Phase I : All CKD patients will undergo echocardiographic evaluation to determine the prevalence of LVH.
- Phase II : Among anemic CKD patients with LVH receiving erythropoietin therapy , will be followed for 6 months
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: khaled M Mohamedein, MBCHB
- Phone Number: +201507290373
- Email: drkhaledmmm1984@gmail.com
Study Contact Backup
- Name: Marwa Z Elsayed, MD
- Phone Number: +201007100970
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adults (≥18 years) diagnosed with CKD stages 3-5.
- Stable clinical condition for ≥3 months.
- Anemia (Hb <10 g/dL) for cohort phase.
- Willingness to participate and provide informed consent.
Exclusion Criteria:
- Valvular or ischemic heart disease.
- Uncontrolled hypertension (BP >180/110 mmHg).
- Acute coronary syndrome or decompensated heart failure in the past 3 months.
- Malignancy or active infection
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in LVMI following erythropoietin therapy in anemic CKD patients.
Time Frame: - baseline transthoracic echocardiography will be performed for all group study.
|
- baseline transthoracic echocardiography will be performed for all group study.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Association between hemoglobin level and LVMI.
Time Frame: 6 months of erythropoitin therapy , transthoracic echocardiography will be performed for all group study.
|
6 months of erythropoitin therapy , transthoracic echocardiography will be performed for all group study.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Amal Kh Ahmed, MD, Sohag university- faculty of medicine - internal medicine department
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Soh-Med--25-11-7MS
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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