Statin Therapy for Ischemic and Nonischemic Cardiomyopathy

NCT ID: NCT00701220

Last Updated: 2023-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-30
• Study Completion Date: 2010-12-31

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.

Conditions

Cardiovascular Disease; Cardiomyopathy; Heart Disease; Myocardial Disease; Myocardial Ischemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ischemic Cardiomyopathy

Patients with Ischemic Cardiomyopathy receiving Lipitor (Atorvastatin calcium).

Group Type: ACTIVE_COMPARATOR

Atorvastatin Calcium

Intervention Type: DRUG

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.

Non Ischemic Cardiomyopathy

NonIschemic Cardiomyopathy receiving Lipitor (Atorvastatin calcium) treatment

Group Type: ACTIVE_COMPARATOR

Atorvastatin Calcium

Intervention Type: DRUG

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.

Healthy Subjects

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Lipitor

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

Philip Binkley

OTHER

Sponsor Role: lead

Responsible Party

Philip Binkley

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Philip Binkley, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

The Ohio State University

Columbus, Ohio, United States

Countries

United States

References

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

Reference Type: BACKGROUND

Other Identifiers

2005H0118

Identifier Type: -

Identifier Source: org_study_id