Statin Therapy for Ischemic and Nonischemic Cardiomyopathy - Full Text View

Sponsors and Collaborators:	Ohio State University Pfizer
Information provided by:	Ohio State University
ClinicalTrials.gov Identifier:	NCT00701220

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 IV

MedlinePlus related topics: Cardiomyopathy Cholesterol Heart Diseases Statins

Drug Information available for: Atorvastatin Atorvastatin calcium Calcium gluconate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Parallel Assignment, Pharmacodynamics Study
Official Title:	Statin Induced Augmentation of Circulating Endothelial Progenitor Cells and Myocardial Viability in Patients With Ischemic and Nonischemic Cardiomyopathy

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
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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.
2: Active Comparator 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.
3: No Intervention 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

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

Contacts

Contact: Amanda Lesinski, BS	614- 247-7754	amanda.lesinski@osumc.edu
Contact: Amit Doshi, MD	614-293-4967	Amit.Doshi@osumc.edu

Locations

United States, Ohio
The Ohio State University	Recruiting
Columbus, Ohio, United States, 43210
Contact: Amanda Lesinski, BS 614-247-7754 amanda.lesinski@osumc.edu
Contact: Phillip Binkley, MD, MPH 614-293-4967 Phillip.Binkley@osumc.edu
Principal Investigator: Phillip Binkley, MD, MPH

Sponsors and Collaborators

Ohio State University

Pfizer

Investigators

Principal Investigator:

Phillip Binkley, MD, MPH

Ohio State University

More Information

No publications provided

Responsible Party:	The Ohio State University/ Division of Cardiovascular Medicine ( Phillip Binkley, MD, MPH )
Study ID Numbers:	2005H0118
Study First Received:	December 26, 2007
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00701220 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Ohio State University:

Cardiovascular Disease
Cardiomyopathy
Heart Disease
Myocardial Disease
Myocardial Ischemia

Study placed in the following topic categories:

Antimetabolites
Calcium, Dietary
Heart Diseases
Antilipemic Agents
Myocardial Ischemia
Vascular Diseases

Anticholesteremic Agents
Ischemia
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Cardiomyopathies
Atorvastatin

Additional relevant MeSH terms:

Antimetabolites
Heart Diseases
Molecular Mechanisms of Pharmacological Action
Myocardial Ischemia
Antilipemic Agents
Vascular Diseases
Enzyme Inhibitors
Ischemia

Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Cardiomyopathies
Pharmacologic Actions
Pathologic Processes
Therapeutic Uses
Cardiovascular Diseases
Atorvastatin

ClinicalTrials.gov processed this record on May 07, 2009