Statin Therapy for Ischemic and Nonischemic Cardiomyopathy



Status:Completed
Conditions:Angina, Peripheral Vascular Disease, Peripheral Vascular Disease, Cardiology, Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 85
Updated:10/14/2017
Start Date:April 2007
End Date:December 2010

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Statin Induced Augmentation of Circulating Endothelial Progenitor Cells and Myocardial Viability in Patients With Ischemic and Nonischemic Cardiomyopathy

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.

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.

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
We found this trial at
1
site
281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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