The Effect of Atorvastatin on Endothelial Cell Dysfunction in Chronic Kidney Disease

Phase 4

Terminated

• Conditions: Chronic Kidney Disease; High Cholesterol
• Interventions: Drug: Atorvastatin

• Registration Number: NCT02133534
• Lead Sponsor: Duke University

Brief Summary

The purpose of this study is to see if patients with chronic kidney disease have endothelial cells that don't function properly, which is thought to be a marker for cardiovascular risk. Endothelial cells line the heart and blood vessels. The investigators will treat your high cholesterol with a cholesterol-lowering drug (atorvastatin, or Lipitor). They will determine if this cholesterol lowering drug improves subjects' cholesterol as well as the function of endothelial cells.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Study First Submitted: 2014-05-06
• Study First Submitted QC: 2014-05-06
• Study First Posted: 2014-05-08
• Status Verified: 2014-06
• Results First Submitted: 2014-06-03
• Results First Submitted QC: 2014-06-03
• Last Update Submitted: 2014-06-03
• Results First Posted: 2014-07-03
• Last Update Posted: 2014-07-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

• Stage 3, 4 and 5 chronic kidney disease (not on dialysis)
• Hyperlipidemia requiring cholesterol lowering therapy
• Aged 18 to 80 years old
• Ability to provide informed consent

Exclusion Criteria

• Patients requiring multiple cholesterol reducing agents
• Patients with neovascularization present, such as neoplasm, active wounds, or significant retinopathy
• Patients with contraindications or allergy to statins

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Atorvastatin	Atorvastatin	Subjects will be treated with atorvastatin 10 mg/day for 30 days. The study team will obtain one blood and urine sample at baseline prior to starting atorvastatin therapy, and again after 30 days of drug therapy. The study team will do ultrasound imaging of the arm in which a probe will be placed over the blood vessels to measure the diameter of the artery and how this changes after a blood pressure cuff is inflated and then deflated. Subjects will take one nitroglycerine tablet during the ultrasound imaging.

Primary Outcome Measures

Name	Time	Method
Improved Counts of Endothelial Progenitor Cells	baseline, 30 days	Improvement of endothelial cell (EC) dysfunction will be assessed by improved counts of endothelial progenitor cells.