Statin Therapy for Ischemic and Nonischemic Cardiomyopathy

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to see if taking a cholesterol lowering drug (LIPITOR®) 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ohio State University
• Collaborator: Pfizer
• Treatments: Atorvastatin; Atorvastatin Calcium; Calcium

Criteria

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