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

Duke University

Status and phase: Terminated; Phase 4

Conditions: Chronic Kidney Disease; High Cholesterol

Treatments: Drug: Atorvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT02133534

Pro00011172

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

Atorvastatin

Experimental group

Description:

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.

Treatment:

Drug: Atorvastatin