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Statin Therapy for Ischemic and Nonischemic Cardiomyopathy

Primary Purpose

Cardiovascular Disease, Cardiomyopathy, Heart Disease

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Atorvastatin Calcium
Sponsored by
Philip Binkley
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiovascular Disease focused on measuring Cardiovascular Disease, Cardiomyopathy, Heart Disease, Myocardial Disease, Myocardial Ischemia

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Ohio State University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Ischemic Cardiomyopathy

Non Ischemic Cardiomyopathy

Healthy Subjects

Arm Description

Patients with Ischemic Cardiomyopathy receiving Lipitor (Atorvastatin calcium).

NonIschemic Cardiomyopathy receiving Lipitor (Atorvastatin calcium) treatment

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

Outcomes

Primary Outcome Measures

Change in Endothelial Progenitor Cells
Change in Endothelial Progenitor Cells (EPC) was assessed by extracting white blood cells from blood samples and labeling the white blood cells using the ALDEFLOUR system. Facscan analysis was then performed first isolating lymphocytic and monocytic cell lines, which contain the EPC populations, using forward versus side scatter plots. These cells were then scanned for fluorescence in the ALDEFLUOR frequency range allowing enumeration of progenitor cell lines. The measures of fluorescent cells was compared to numbers of unstained cells having the same back scatter range to correct for any background fluorescence.
Percentage Aldofluor Positive Cells
The primary outcome measure is the percentage of cells of total analyzed that are positive for the Aldofluor assay. This commercially available assay tests cells for the enzyme aldehyde dehydrogenase that is expressed in stem cells and other early life cycle undifferentiated cells. It thus provides a measure of circulating primordial cells or cells that may serve as progenitors of destination mature cells. The percentages are designed from Facscan analysis of prepared blood cells and are quantified by quadrants defined by specific fluorescent bands and cell size distribution. The quantification of cells thus defined in the four quadrants is automatically determined by software resident in the facscan analysis system.

Secondary Outcome Measures

Full Information

First Posted
December 26, 2007
Last Updated
June 28, 2023
Sponsor
Philip Binkley
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00701220
Brief Title
Statin Therapy for Ischemic and Nonischemic Cardiomyopathy
Official Title
Statin Induced Augmentation of Circulating Endothelial Progenitor Cells and Myocardial Viability in Patients With Ischemic and Nonischemic Cardiomyopathy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Philip Binkley
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Disease, Cardiomyopathy, Heart Disease, Myocardial Disease, Myocardial Ischemia
Keywords
Cardiovascular Disease, Cardiomyopathy, Heart Disease, Myocardial Disease, Myocardial Ischemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ischemic Cardiomyopathy
Arm Type
Active Comparator
Arm Description
Patients with Ischemic Cardiomyopathy receiving Lipitor (Atorvastatin calcium).
Arm Title
Non Ischemic Cardiomyopathy
Arm Type
Active Comparator
Arm Description
NonIschemic Cardiomyopathy receiving Lipitor (Atorvastatin calcium) treatment
Arm Title
Healthy Subjects
Arm Type
No Intervention
Arm Description
Healthy subjects with no history of high cholesterol, heart disease, or heart attacks
Intervention Type
Drug
Intervention Name(s)
Atorvastatin Calcium
Other Intervention Name(s)
Lipitor
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Endothelial Progenitor Cells
Description
Change in Endothelial Progenitor Cells (EPC) was assessed by extracting white blood cells from blood samples and labeling the white blood cells using the ALDEFLOUR system. Facscan analysis was then performed first isolating lymphocytic and monocytic cell lines, which contain the EPC populations, using forward versus side scatter plots. These cells were then scanned for fluorescence in the ALDEFLUOR frequency range allowing enumeration of progenitor cell lines. The measures of fluorescent cells was compared to numbers of unstained cells having the same back scatter range to correct for any background fluorescence.
Time Frame
Baseline - 6 months
Title
Percentage Aldofluor Positive Cells
Description
The primary outcome measure is the percentage of cells of total analyzed that are positive for the Aldofluor assay. This commercially available assay tests cells for the enzyme aldehyde dehydrogenase that is expressed in stem cells and other early life cycle undifferentiated cells. It thus provides a measure of circulating primordial cells or cells that may serve as progenitors of destination mature cells. The percentages are designed from Facscan analysis of prepared blood cells and are quantified by quadrants defined by specific fluorescent bands and cell size distribution. The quantification of cells thus defined in the four quadrants is automatically determined by software resident in the facscan analysis system.
Time Frame
Baseline - 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip Binkley, MD, MPH
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
available through request to the principal investigator; has been presented as an abstract but not a published paper
IPD Sharing Time Frame
Is available now and indefinitely
IPD Sharing Access Criteria
Investigators in the field of biomedical research
Citations:
Citation
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
Results Reference
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Statin Therapy for Ischemic and Nonischemic Cardiomyopathy

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