Statin Therapy for Ischemic and Nonischemic Cardiomyopathy

Phase 4

Completed

Conditions: Cardiovascular Disease
Heart Disease
Cardiomyopathy
Myocardial Disease
Myocardial Ischemia

Brief Summary: The purpose of this study is to see if taking a cholesterol lowering drug Lipitor (Atorvastatin Calcium)will increase the number of endothelial progenitor cells (EPC's) circulating in the blood of heart failure patients taking this cholesterol-lowering drug, and if this will also show an improvement in the damaged areas of the patient's hearts as documented by MRI scans.

Detailed Description: This study involves the testing of blood for cholesterol levels and flow cytometry tests to count the number of EPC's in your blood. These tests are routinely performed to gain knowledge about a person's health. If any incidental findings are identified as a result of your participation in this research study, you will be notified and referred to your doctor or appropriate health care professional.

You are being asked to provide a blood sample that will be used to determine the usual numbers of EPC's circulating in the blood of healthy people who have no risk factors for heart disease. Your results will be compared with those of patients who have heart failure.

Flow cytometry is a special laboratory test that can count, separate, and detect characteristics of cells in blood. Your blood sample will be analyzed using flow cytometry. Endothelial progenitor cells (EPC's) are immature cells that are necessary for new blood vessel formation. EPC's will be separated by flow cytometry and counted. You will not be given the results of your flow cytometry study.

Recruitment & Eligibility

Inclusion Criteria

Ischemic Cardiomyopathy (as defined above) with ejection fraction < 35%
Non-ischemic Cardiomyopathy with ejection fraction < 35%
NCEP ATPIII indication for therapy with a statin drug
No statin therapy within previous 6 months of study enrollment
Prescribed stable doses of standard heart failure therapies including beta blocking agents, angiotensin converting enzyme inhibitors or angiotensin receptor blockers, and diuretic agents as required

Exclusion Criteria

Pregnant or lactating
Myocardial infarction within 6 months preceding study enrollment
Primary valvular heart disease
Surgical or catheter based revascularization within the preceding 6 months
Documented viral or inflammatory myocarditis or cardiomyopathy
Peripartum cardiomyopathy
Infiltrative cardiomyopathies
Chemotherapy associated cardiomyopathy
Without indication for statin therapy
Contraindication to statin therapy including hepatic dysfunction, history of rhabdomyolysis or prior intolerance of statin therapy
Contraindication to magnetic resonance imaging

Arm && Interventions

Group	Intervention	Description
Ischemic Cardiomyopathy	Atorvastatin Calcium	Patients with Ischemic Cardiomyopathy receiving Lipitor (Atorvastatin calcium).
Non Ischemic Cardiomyopathy	Atorvastatin Calcium	NonIschemic Cardiomyopathy receiving Lipitor (Atorvastatin calcium) treatment

Primary Outcome Measures

Name	Time	Method
Change in Endothelial Progenitor Cells	Baseline - 6 months	Change in Endothelial Progenitor Cells (EPC) was assessed by extracting white blood cells from blood samples and labeling the white blood cells using the ALDEFLOUR system. Facscan analysis was then performed first isolating lymphocytic and monocytic cell lines, which contain the EPC populations, using forward versus side scatter plots. These cells were then scanned for fluorescence in the ALDEFLUOR frequency range allowing enumeration of progenitor cell lines. The measures of fluorescent cells was compared to numbers of unstained cells having the same back scatter range to correct for any background fluorescence.
Percentage Aldofluor Positive Cells	Baseline - 6 months	The primary outcome measure is the percentage of cells of total analyzed that are positive for the Aldofluor assay. This commercially available assay tests cells for the enzyme aldehyde dehydrogenase that is expressed in stem cells and other early life cycle undifferentiated cells. It thus provides a measure of circulating primordial cells or cells that may serve as progenitors of destination mature cells. The percentages are designed from Facscan analysis of prepared blood cells and are quantified by quadrants defined by specific fluorescent bands and cell size distribution. The quantification of cells thus defined in the four quadrants is automatically determined by software resident in the facscan analysis system.

Secondary Outcome Measures