Statin Therapy for Ischemic and Nonischemic Cardiomyopathy

NCT00701220 | Completed Phase 4 Results

• 1 other identifier: 2005H0118
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Disease; Cardiomyopathy; Heart Disease; Myocardial Disease; Myocardial Ischemia

Keywords

Cardiovascular Disease; Cardiomyopathy; Heart Disease; Myocardial Disease; Myocardial Ischemia

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline - 6 months

• 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.

  Baseline - 6 months

Study Arms (3)

Ischemic Cardiomyopathy

ACTIVE COMPARATOR

Patients with Ischemic Cardiomyopathy receiving Lipitor (Atorvastatin calcium).

Drug: Atorvastatin Calcium

Non Ischemic Cardiomyopathy

ACTIVE COMPARATOR

NonIschemic Cardiomyopathy receiving Lipitor (Atorvastatin calcium) treatment

Drug: Atorvastatin Calcium

Healthy Subjects

NO INTERVENTION

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

Interventions

Atorvastatin Calcium DRUG

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.

Also known as: Lipitor

Ischemic Cardiomyopathy; Non Ischemic Cardiomyopathy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Philip Binkley: lead
• Pfizer: collaborator

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

• 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

  BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases; Cardiomyopathies; Heart Diseases; Myocardial Ischemia

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Vascular Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Results Point of Contact

• Title: Philip F. Binkley, MD, MPH
• Organization: The Ohio State University

binkley.2@osu.edu

(614) 293-3956

Study Officials

• Philip Binkley, MD, MPH

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 26, 2007
• First Posted: June 19, 2008
• Study Start: April 1, 2007
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: July 18, 2023
• Results First Posted: July 18, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Is available now and indefinitely
• Access Criteria: Investigators in the field of biomedical research

Locations

US (1)