Effects of Cilostazol on VEGF and Oxidative Stress Biomarkers in Hemodialysis Patients With Peripheral Vascular Disease

• Status: Completed
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Peripheral arterial disease (PAD) is the most common manifestation of systemic atherosclerosis and accounts for significant morbidity and mortality among end-stage renal disease (ESRD) patients. However, few studies have identified the prevalence and clinical impact of PAD in this specific population.

Objectives: To perform a single-blinded parallel, controlled trial to examine the effect of cilostazol treatment on plasma VEGF levels, tissue factors , inflammatory markers (such as IL-6, hsCRP) levels, oxidative stress markers in ESRD patients with PAD Material and methods Fourty HD patients on maintenance HD for > 3months were enrolled in this prospective, single-blinded, randomized study. These patients were randomly allocated into 2 arms. After baseline assessment, patients in the treatment arm received 12 weeks of added on therapy with cilostazol 100mg/day. Blood pressure, heart rate, oxidative stress (malonyldialdehyde, protein carbonyl and ADMA), inflammatory markers (hsCRP, IL-6) and plasma, VEGF and tissue factors levels were measured before and after treatment.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Tungs' Taichung Metroharbour Hospital; Tungs’ Taichung Metroharbour Hospital
• Treatments: Cilostazol; Endothelial Growth Factors

Criteria

Inclusion Criteria:

1. Both sexes aged between 30-70 years

2. Non-diabetic ESRD Patients on HD greater than 3 months

3. Patients with PAD diagnosed by clinical symptoms, and ABI indices < 0.9 and confirmed by angiographic or related studies.

4. Written informed consent

Exclusion Criteria:

1. Known allergy to cilostazol

2. Patients who currently have had pentoxyphylline or related therapy

3. Congestive heart failure or cardiac arrhythmia

4. Severe liver impairment

5. Patients with malignancy or acute/chronic inflammatory diseases

6. Smoking during the previous 6 months

7. Recent stroke

8. Severe dyslipidemia (triglycerides >600 mg/dL or total cholesterol >300g/dL) or currently on statin therapy