Effects of Cilostazol on VEGF and Oxidative Stress Biomarkers in Hemodialysis Patients With Peripheral Vascular Disease
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hemodialysis Patients Peripheral Vascular Disease |
Drug: Cilostazol |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Treatment |
| Official Title: | Effects of Cilostazol on Vascular Endothelial Growth Factor , Inflammatory and Oxidative Stress Biomarkers in Hemodialysis Patients With Peripheral Vascular Disease. |
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| Estimated Enrollment: | 70 |
| Study Start Date: | February 2007 |
| Study Completion Date: | April 2008 |
Show Detailed Description Eligibility| Ages Eligible for Study: | 30 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Both sexes aged between 30-70 years
- Non-diabetic ESRD Patients on HD greater than 3 months
- Patients with PAD diagnosed by clinical symptoms, and ABI indices < 0.9 and confirmed by angiographic or related studies.
- Written informed consent
Exclusion Criteria:
- Known allergy to cilostazol
- Patients who currently have had pentoxyphylline or related therapy
- Congestive heart failure or cardiac arrhythmia
- Severe liver impairment
- Patients with malignancy or acute/chronic inflammatory diseases
- Smoking during the previous 6 months
- Recent stroke
- Severe dyslipidemia (triglycerides >600 mg/dL or total cholesterol >300g/dL) or currently on statin therapy
Contacts and Locations More Information
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| ClinicalTrials.gov Identifier: | NCT00431249 History of Changes |
| Other Study ID Numbers: | 960126 |
| Study First Received: | February 2, 2007 |
| Last Updated: | April 4, 2008 |
| Health Authority: | Taiwan: Department of Health |
Additional relevant MeSH terms:
|
Vascular Diseases Peripheral Vascular Diseases Peripheral Arterial Disease Cardiovascular Diseases Atherosclerosis Arteriosclerosis Arterial Occlusive Diseases Cilostazol Endothelial Growth Factors Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cardiovascular Agents Therapeutic Uses |
Hematologic Agents Platelet Aggregation Inhibitors Vasodilator Agents Neuroprotective Agents Protective Agents Physiological Effects of Drugs Central Nervous System Agents Phosphodiesterase 3 Inhibitors Phosphodiesterase Inhibitors Enzyme Inhibitors Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents |
ClinicalTrials.gov processed this record on May 21, 2013