Effect of erythropoietin stimulating agent on endothelial function in non-dialysis chronic kidney disease patients
- Conditions
- Diseases of the genitourinary system
- Registration Number
- KCT0003914
- Lead Sponsor
- GangNeung Asan Hospital
- Brief Summary
Background: This study investigated whether administering erythropoiesis-stimulating agents (ESAs) improves endothelial function in patients with non-dialysis chronic kidney disease (CKD) and anemia. Methods: This single-center, prospective, single-arm comparison study enrolled patients with non-dialysis CKD (stages 4-5) and hemoglobin levels <10g/dL. ESA administration followed the Kidney Disease: Improving Global Outcomes guideline. The primary endpoint was the change in flow-mediated dilatation after ESA administration in individual patients. The secondary endpoints were changes in 6-minute walk test results, blood pressure, New York Heart Association class, and echocardiographic parameters. The echocardiographic parameters examined included chamber quantification, Doppler parameters, and systolic and diastolic function parameters. Results: Initially, 13 patients were screened, but 2 discontinued due to either heart failure or voluntary withdrawal. The mean flowmediated dilatation values significantly increased by 10.59% (from 1.36%±1.91% to 11.95%±8.11%, P=.001). Echocardiographic findings showed that the left ventricular mass index decreased by 11.9g/m2 (from 105.8±16.3 to 93.9±19.5g/m2, P=.006), and the left atrial volume index decreased by 10.8mL/m2 (from 50.1±11.3 to 39.3±11.3mL/m2, P=.004) after 12weeks of ESA administration. There were no significant differences between pre- and post-ESA treatment 6-minute walk test results. No significant side effects were observed during the study period. Conclusions: This is the first clinical study to demonstrate that an ESA improves endothelial dysfunction, left ventricular hypertrophy, and left atrial volume in patients with non-dialysis CKD. Thus, ESAs may be considered as adjunctive therapy for reducing cardiovascular risk in these patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 13
a person who has signed a written consent form of 10,000 to 20 years of age or older.
Patients with chronic kidney disease stage 4,5 (GFR 10-30 ml/min/1.73 m2) without dialysis
Blood colouring (Hb) < 10 mg/dL
Heart retraction function is normal (LVEF > 55%)
a history of erythropoietin administration within the last three months.
A person who is subject to or needs to perform dialysis.
Uncontrolled hypertension
an expected life expectancy of less than one year
Someone who needs surgery for meaningful valve disease
Any person who has evidence of acute coronary syndrome within 60 days;
Patients with heart failure due to acute myocarditis, limited myocardial infarction and deadlocked myocardial infarction
Anemia with severe bleeding (Hb < 7 mg/dL)
Persons with other diseases (e.g. chronic closed lung disease)
Heart failure patients with meaningful arrhythmia (VCD, V-V-V, V-V-V-V-V-V-V-V-V-V-V-V-P)
Total bilirubin > 3 mg/dL, albumin < 2.8 mg/dL)
Pregnant women, nursing mothers
Persons currently participating in other clinical trials
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method function of endothelial cell
- Secondary Outcome Measures
Name Time Method ew York Heart Association class