Statin Therapy for Ischemic and Nonischemic Cardiomyopathy

Philip Binkley

Status and phase: Completed; Phase 4

Conditions: Cardiomyopathy; Myocardial Ischemia; Myocardial Disease; Heart Disease; Cardiovascular Disease

Treatments: Drug: Atorvastatin Calcium

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00701220

2005H0118

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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9 participants in 3 patient groups

Ischemic Cardiomyopathy

Active Comparator group

Description:

Patients with Ischemic Cardiomyopathy receiving Lipitor (Atorvastatin calcium).

Treatment:

Drug: Atorvastatin Calcium

Non Ischemic Cardiomyopathy

Active Comparator group

Description:

NonIschemic Cardiomyopathy receiving Lipitor (Atorvastatin calcium) treatment

Treatment:

Drug: Atorvastatin Calcium

Healthy Subjects

No Intervention group

Description:

Healthy subjects with no history of high cholesterol, heart disease, or heart attacks