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

• Sponsor: Federal University of São Paulo (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00291863
• Collaborator: (none)
• Enrollment: 30
• Location: 1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Renal Failure, End Stage; Peritoneal Dialysis	Drug: Simvastatin	Phase 4

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.

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: Simvastatin Effect on Endothelium Dependent Venodilation in Chronic Renal Failure Patients Treated by Peritoneal Dialysis
• Study Start Date: Feb 1, 2006
• Study Completion Date: Feb 1, 2006

Outcome Measures

Primary Outcome Measures

1. endothelial venodilation []

Secondary Outcome Measures

1. Inflammation markers (C-reactive protein, IL-6, TNF) []

2. Lipoproteins []

3. Oxidative stress []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	São Lucas Hospital	Porto Alegre	Rio Grande do Sul	Brazil

Sponsors and Collaborators

• Federal University of São Paulo

Investigators

• Principal Investigator: Maristela Bohlke, master, Federal University of São Paulo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00291863
• Other Study ID Numbers: 0089/04
• First Posted: Feb 15, 2006
• Last Update Posted: Feb 16, 2006
• Last Verified: Feb 1, 2006

• Keywords provided by , ,: end stage renal failure; peritoneal dialysis; simvastatin; endothelium; vasodilation
• Additional relevant MeSH terms: Renal Insufficiency; Kidney Failure, Chronic; Simvastatin

Study Results

No Results Posted as of Feb 16, 2006