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

This study has been completed.
Sponsor:
Information provided by:
Tungs’ Taichung Metroharbour Hospital
ClinicalTrials.gov Identifier:
NCT00431249
First received: February 2, 2007
Last updated: April 4, 2008
Last verified: February 2007
  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.

Resource links provided by NLM:


Further study details as provided by Tungs’ Taichung Metroharbour Hospital:

Primary Outcome Measures:
  • no numbers

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
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00431249

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

No publications provided

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
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Vasodilator Agents
Neuroprotective Agents
Protective Agents
Central Nervous System Agents
Phosphodiesterase 3 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on October 01, 2014