We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00431249
First Posted: February 5, 2007
Last Update Posted: May 12, 2015
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.
Information provided by (Responsible Party):
Paik Seong Lim, Tungs' Taichung Metroharbour Hospital
  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: 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.

Resource links provided by NLM:


Further study details as provided by Paik Seong Lim, Tungs' Taichung Metroharbour Hospital:

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

Enrollment: 40
Study Start Date: February 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
one Drug: Cilostazol

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): NCT00431249


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

Responsible Party: Paik Seong Lim, MD, Tungs' Taichung Metroharbour Hospital
ClinicalTrials.gov Identifier: NCT00431249     History of Changes
Other Study ID Numbers: 960126
First Submitted: February 2, 2007
First Posted: February 5, 2007
Last Update Posted: May 12, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Cilostazol
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