Status:
COMPLETED
Statin Therapy in Heart Failure: Potential Mechanisms of Benefit
Lead Sponsor:
University of California, Los Angeles
Collaborating Sponsors:
Pfizer
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Heart Failure, Congestive
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The goal of the investigators' study is to further understand the potentially beneficial effects of statin therapy in patients with heart failure. It is hypothesized that statins will 1) increase the ...
Detailed Description
Recent evidence suggests that HMG-Coenzyme A (statin) therapy may be associated with improved survival in both ischemic and non-ischemic heart failure (HF). Large, randomized outcome studies of statin...
Eligibility Criteria
Inclusion
- Age≥18 years old
- LVEF ≤ 35%, as documented by echocardiography, radionuclide ventriculography, gated SPECT, or contrast ventriculography within past 6 months
- Symptomatic HF (NYHA II-IV) or current NYHA I with history of symptomatic HF within the last year
- Stable doses of optimal HF medical therapy, unless documented contraindication.
Exclusion
- Ischemic etiology of HF, defined as the presence of at least one of the following four criteria; angiographic evidence of \> 50% lesion in 1 or more of the 3 major epicardial vessels; history of myocardial infarction; history of revascularization procedure; evidence of significant perfusion defect in the setting of ischemic symptoms.
- Clinical indication for statin treatment - coronary artery, cerebrovascular, or peripheral vascular disease
- Major cardiovascular event or surgical procedure within past 8 weeks
- LDL\<70 mg/dL
- HF secondary to congenital heart disease or uncorrected valvular disease
- Treatment with statin within past 2 months
- Pregnancy
- Contraindication to statin: moderate liver disease, AST/ALT \> 150 U/ L, known hypersensitivity
- Likely to receive heart transplant within 3 months
- Known peripheral or autonomic neuropathy
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00233480
Start Date
August 1 2005
End Date
February 1 2009
Last Update
March 20 2020
Active Locations (1)
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1
Ahmanson-UCLA Cardiomyopathy Center
Los Angeles, California, United States, 90095