Statin Therapy for Ischemic and Nonischemic Cardiomyopathy

Cardiovascular Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00701220
• Other study ID #: 2005H0118
• Status: Completed
• Phase: Phase 4
• Start date: April 2007
• Est. completion date: December 2010

Study information

• Verified date: June 2023
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy
• Cardiovascular Disease
• Cardiovascular Diseases
• Coronary Artery Disease
• Heart Disease
• Heart Diseases
• Ischemia
• Myocardial Disease
• Myocardial Ischemia

Intervention

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.

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Philip Binkley	Pfizer

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Endothelial Progenitor Cells	Change in Endothelial Progenitor Cells (EPC) was assessed by extracting white blood cells from blood samples and labeling the white blood cells using the ALDEFLOUR system. Facscan analysis was then performed first isolating lymphocytic and monocytic cell lines, which contain the EPC populations, using forward versus side scatter plots. These cells were then scanned for fluorescence in the ALDEFLUOR frequency range allowing enumeration of progenitor cell lines. The measures of fluorescent cells was compared to numbers of unstained cells having the same back scatter range to correct for any background fluorescence.	Baseline - 6 months
Primary	Percentage Aldofluor Positive Cells	The primary outcome measure is the percentage of cells of total analyzed that are positive for the Aldofluor assay. This commercially available assay tests cells for the enzyme aldehyde dehydrogenase that is expressed in stem cells and other early life cycle undifferentiated cells. It thus provides a measure of circulating primordial cells or cells that may serve as progenitors of destination mature cells. The percentages are designed from Facscan analysis of prepared blood cells and are quantified by quadrants defined by specific fluorescent bands and cell size distribution. The quantification of cells thus defined in the four quadrants is automatically determined by software resident in the facscan analysis system.	Baseline - 6 months