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Simvastatin Effect on End Stage Renal Failure Patients Treated by Peritoneal Dialysis

Information source: Federal University of São Paulo
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Renal Failure, End Stage; Peritoneal Dialysis

Intervention: Simvastatin (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Federal University of São Paulo

Official(s) and/or principal investigator(s):
Maristela Bohlke, master, Principal Investigator, Affiliation: Federal University of São Paulo

Overall contact:
Maristela Bohlke, MD, Phone: 55 53 32264098, Email: mbohlke@conesul.com.br

Summary

This study will analyse the effect of simvastatin on endothelium dependent venodilation in chronic renal failure patients treated by peritoneal dialysis. The hypothesis is that patients will have a greater endothelium dependent venodilation after four months of simvastatin use.

Clinical Details

Official title: Simvastatin Effect on Endothelium Dependent Venodilation in Chronic Renal Failure Patients Treated by Peritoneal Dialysis

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: endothelial venodilation

Secondary outcome:

Inflammation markers (C-reactive protein, IL-6, TNF)

Lipoproteins

Oxidative stress

Detailed description: This study will analyse the effect of simvastatin on endothelium dependent venodilation in chronic renal failure patients treated by peritoneal dialysis. The hypothesis is that patients will have a greater endothelium dependent venodilation after four months of simvastatin use.

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- end stage renal failure

- peritoneal dialysis

- LDL cholesterol > 100mg/dL

- > 18 years and < 80 years

Exclusion Criteria:

- using statin or nitrate

- liver disease

- diabetes mellitus

Locations and Contacts

Maristela Bohlke, MD, Phone: 55 53 32264098, Email: mbohlke@conesul.com.br

São Lucas Hospital, Porto Alegre, Rio Grande do Sul, Brazil; Recruiting
Carlos Eduardo P Figueiredo, PhD, Principal Investigator
Additional Information

Starting date: February 2006
Ending date: February 2006
Last updated: February 15, 2006

Page last updated: November 03, 2008

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