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

NCT ID: NCT02133534

Last Updated: 2014-07-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2009-05-31

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.

Conditions

Chronic Kidney Disease; High Cholesterol

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Atorvastatin

Intervention Type: DRUG

Interventions

Atorvastatin

Intervention Type: DRUG

Other Intervention Names

Lipitor

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lynda Szczech, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Other Identifiers

Pro00011172

Identifier Type: -

Identifier Source: org_study_id