Statin Therapy for Ischemic and Nonischemic Cardiomyopathy

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
Ohio State University
ClinicalTrials.gov Identifier:
NCT00701220
First received: December 26, 2007
Last updated: April 12, 2011
Last verified: April 2011
  Purpose

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.


Condition Intervention Phase
Cardiovascular Disease
Cardiomyopathy
Heart Disease
Myocardial Disease
Myocardial Ischemia
Drug: Atorvastatin Calcium
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Statin Induced Augmentation of Circulating Endothelial Progenitor Cells and Myocardial Viability in Patients With Ischemic and Nonischemic Cardiomyopathy

Resource links provided by NLM:


Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • Increase in Endothelial Progenitor Cells [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Increase in left ventricular ejection faction [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: April 2007
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Patients with Ischemic Cardiomyopathy receiving Lipitor.
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
Active Comparator: 2
NonIschemic Cardiomyopathy receiving Lipitor treatment
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
No Intervention: 3
Healthy subjects with no history of high cholesterol, heart disease, or heart attacks

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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00701220

Locations
United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
Pfizer
Investigators
Principal Investigator: Philip Binkley, MD, MPH Ohio State University
  More Information

No publications provided

Responsible Party: Philip Binkley, MD, MPH, The Ohio State University/ Division of Cardiovascular Medicine
ClinicalTrials.gov Identifier: NCT00701220     History of Changes
Other Study ID Numbers: 2005H0118
Study First Received: December 26, 2007
Last Updated: April 12, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University:
Cardiovascular Disease
Cardiomyopathy
Heart Disease
Myocardial Disease
Myocardial Ischemia

Additional relevant MeSH terms:
Cardiovascular Diseases
Myocardial Ischemia
Coronary Artery Disease
Heart Diseases
Ischemia
Cardiomyopathies
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Pathologic Processes
Atorvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 26, 2014