Statin Therapy for Ischemic and Nonischemic Cardiomyopathy

Sponsor

Ohio State University (Other)

Overall Status

Completed

CT.gov ID

NCT00701220

Collaborator

Pfizer (Industry)

Enrollment

Location

Arms

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Disease Cardiomyopathy Heart Disease Myocardial Disease Myocardial Ischemia	Drug: Atorvastatin Calcium	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2007

Actual Primary Completion Date :

Dec 1, 2010

Actual Study Completion Date :

Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 Patients with Ischemic Cardiomyopathy receiving Lipitor.	Drug: Atorvastatin Calcium Atorvastatin Calcium starting at a 10 mg dose and may be increased up to 40 mg dose until cholesterol is lowered to an acceptable range. Blood will drawn every 2 weeks for the first 12 weeks to check the cholesterol level and adjust medication dosage. Cardiac MRI will be performed at the beginning and at the end of the 6 month study to measure the physical changes of the heart. Other Names: Lipitor
Active Comparator: 2 NonIschemic Cardiomyopathy receiving Lipitor treatment	Drug: Atorvastatin Calcium Atorvastatin Calcium starting at a 10 mg dose and may be increased up to 40 mg dose until cholesterol is lowered to an acceptable range. Blood will drawn every 2 weeks for the first 12 weeks to check the cholesterol level and adjust medication dosage. Cardiac MRI will be performed at the beginning and at the end of the 6 month study to measure the physical changes of the heart. Other Names: Lipitor
No Intervention: 3 Healthy subjects with no history of high cholesterol, heart disease, or heart attacks

Arm

Intervention/Treatment

Active Comparator: 1

Patients with Ischemic Cardiomyopathy receiving Lipitor.

Drug: Atorvastatin Calcium

Atorvastatin Calcium starting at a 10 mg dose and may be increased up to 40 mg dose until cholesterol is lowered to an acceptable range. Blood will drawn every 2 weeks for the first 12 weeks to check the cholesterol level and adjust medication dosage. Cardiac MRI will be performed at the beginning and at the end of the 6 month study to measure the physical changes of the heart.

Other Names:

Lipitor

Active Comparator: 2

NonIschemic Cardiomyopathy receiving Lipitor treatment

Drug: Atorvastatin Calcium

Other Names:

Lipitor

No Intervention: 3

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

Outcome Measures

Primary Outcome Measures

Increase in Endothelial Progenitor Cells [6 months]

Secondary Outcome Measures

Increase in left ventricular ejection faction [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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