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

NCT00431249 | Completed Phase 4

• 1 other identifier: 960126
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hemodialysis Patients; Peripheral Vascular Disease

Outcome Measures

Primary Outcomes (1)

• Effects on Biomarkers

  12 weeks

Study Arms (1)

one

OTHER

Drug: Cilostazol

Interventions

Cilostazol DRUG

one

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tungs' Taichung Metroharbour Hospital: lead

MeSH Terms

Conditions

Peripheral Vascular Diseases

Interventions

Cilostazol

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Palk Seong Lim, MD

  Tungs' Taichung Metroharbour Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 2, 2007
• First Posted: February 5, 2007
• Study Start: February 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: May 12, 2015

Record last verified: 2015-05