Phase 4 Completed N=9 Treatment

Statin Therapy for Ischemic and Nonischemic Cardiomyopathy

Cardiovascular Disease · Cardiomyopathy · Heart Failure · Myocardial Disease

Source: ClinicalTrials.gov NCT00701220 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2023

Primary outcomePrimary: Change in Endothelial Progenitor Cells — -10.01; 5.19 Percentage of EPCs

◆ Published Evidence

No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

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.

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

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.