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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00431249
Recruitment Status : Completed
First Posted : February 5, 2007
Last Update Posted : May 12, 2015
Information provided by (Responsible Party):
Paik Seong Lim, Tungs’ Taichung Metroharbour Hospital

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.

Condition or disease Intervention/treatment Phase
Hemodialysis Patients Peripheral Vascular Disease Drug: Cilostazol Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
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.
Study Start Date : February 2007
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Cilostazol

Arm Intervention/treatment
one Drug: Cilostazol

Primary Outcome Measures :
  1. Effects on Biomarkers [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00431249

Sponsors and Collaborators
Tungs’ Taichung Metroharbour Hospital
Principal Investigator: Palk Seong Lim, MD Tungs’ Taichung Metroharbour Hospital

Responsible Party: Paik Seong Lim, MD, Tungs’ Taichung Metroharbour Hospital Identifier: NCT00431249     History of Changes
Other Study ID Numbers: 960126
First Posted: February 5, 2007    Key Record Dates
Last Update Posted: May 12, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Cardiovascular Diseases
Arterial Occlusive Diseases
Endothelial Growth Factors
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Vasodilator Agents
Neuroprotective Agents
Protective Agents
Phosphodiesterase 3 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Growth Substances