Phase 4
N=9
Statin Therapy for Ischemic and Nonischemic Cardiomyopathy
Cardiovascular Disease · Cardiomyopathy · Heart Disease · Myocardial Disease · Myocardial Ischemia
Bottom Line
View on ClinicalTrials.gov: NCT00701220 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Jul 2023
Primary outcome: Primary: Change in Endothelial Progenitor Cells — -10.01; 5.19 Percentage of EPCs
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Atorvastatin Calcium (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Philip Binkley
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Endothelial Progenitor Cells |
-10.01; 5.19 | — |
| PRIMARY Percentage Aldofluor Positive Cells |
6.37; 5.7 | <0.05 sig |
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.
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
Data sourced from ClinicalTrials.gov (NCT00701220). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.