Statin Therapy for Ischemic and Nonischemic Cardiomyopathy

NCT00701220

Last updated date
Study Location
The Ohio State University
Columbus, Ohio, 43210, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Cardiovascular Disease, Cardiomyopathy, Heart Disease, Myocardial Disease, Myocardial Ischemia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-85 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Cardiovascular Disease, Cardiomyopathy, Heart Disease, Myocardial Disease, Myocardial IschemiaStatin Therapy for Ischemic and Nonischemic Cardiomyopathy
NCT00701220
  1. Columbus, Ohio
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Statin Therapy for Ischemic and Nonischemic Cardiomyopathy
Official Title  ICMJE Statin Induced Augmentation of Circulating Endothelial Progenitor Cells and Myocardial Viability in Patients With Ischemic and Nonischemic Cardiomyopathy
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cardiovascular Disease
  • Cardiomyopathy
  • Heart Disease
  • Myocardial Disease
  • Myocardial Ischemia
Intervention  ICMJE 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 Name: Lipitor
Study Arms  ICMJE
  • Active Comparator: 1
    Patients with Ischemic Cardiomyopathy receiving Lipitor.
    Intervention: Drug: Atorvastatin Calcium
  • Active Comparator: 2
    NonIschemic Cardiomyopathy receiving Lipitor treatment
    Intervention: Drug: Atorvastatin Calcium
  • No Intervention: 3
    Healthy subjects with no history of high cholesterol, heart disease, or heart attacks
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: June 17, 2008)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00701220
Other Study ID Numbers  ICMJE 2005H0118
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Philip Binkley, MD, MPH, The Ohio State University/ Division of Cardiovascular Medicine
Study Sponsor  ICMJE Ohio State University
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Philip Binkley, MD, MPHOhio State University
PRS Account Ohio State University
Verification Date April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP