CompletedPhase 4

Statin Therapy for Ischemic and Nonischemic Cardiomyopathy

United States9 participantsStarted 2007-04

Plain-language 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.

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Endothelial Progenitor Cells

Timeframe: Baseline - 6 months

Percentage Aldofluor Positive Cells

Timeframe: Baseline - 6 months

Trial details

NCT IDNCT00701220

SponsorPhilip Binkley

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-12

Results submitted2012-05-03

View on ClinicalTrials.gov More Cardiovascular Disease trials