Status:

COMPLETED

Statin Therapy for Ischemic and Nonischemic Cardiomyopathy

Lead Sponsor:

Philip Binkley

Collaborating Sponsors:

Pfizer

Conditions:

Cardiovascular Disease

Cardiomyopathy

Eligibility:

All Genders

18-85 years

Phase:

PHASE4

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 hea...

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 perso...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

April 1 2007

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2010

Estimated Enrollment :

9 Patients enrolled

Trial Details

Trial ID

NCT00701220

Start Date

April 1 2007

End Date

December 1 2010

Last Update

July 18 2023

Active Locations (1)

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1

The Ohio State University

Columbus, Ohio, United States, 43210