Chronic Kidney Disease, High Cholesterol
Conditions
Keywords
Chronic kidney disease, High cholesterol
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.
Interventions
DRUGAtorvastatin
Sponsors
Duke University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Atorvastatin | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | Atorvastatin |
|---|---|
| Age, Customized Greater than 18 Years | 1 participants |
| Region of Enrollment United States | 1 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Improved Counts of Endothelial Progenitor Cells
Improvement of endothelial cell (EC) dysfunction will be assessed by improved counts of endothelial progenitor cells.
Time frame: baseline, 30 days
Population: Early termination because of insufficient accrual. With only one study participant, data could not be analyzed.