Clinical trial NCT00701220: Statin Therapy for Ischemic and Nonischemic Cardiomyopathy
Official title: Statin Induced Augmentation of Circulating Endothelial Progenitor Cells and Myocardial Viability in Patients With Ischemic and Nonischemic Cardiomyopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cardiovascular Disease
Cardiomyopathy
Heart Disease
Myocardial Disease
Myocardial Ischemia
Keywords: Cardiovascular Disease
Cardiomyopathy
Heart Disease
Myocardial Disease
Myocardial Ischemia
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2008-06-19
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Change in Endothelial Progenitor Cells
timeFrame: Baseline - 6 months
measure: Percentage Aldofluor Positive Cells
timeFrame: Baseline - 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Philip Binkley, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abstract 10678: Increase in the Number of Circulating Primordial Cells is Associated With Improved Left Ventricular Function in Dilated Cardiomyopathy Nkechinyere N Ijioma, Philip F Binkley, and Amanda Lesinski Originally published27 Mar 2018Circulation. 2013;128:A10678