Phase 4
N=27
Statin Therapy in Heart Failure: Potential Mechanisms of Benefit
Heart Failure, Congestive
Bottom Line
View on ClinicalTrials.gov: NCT00233480 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcome: Primary: LVEF (Left Ventricular Ejection Fraction) — 24; 28; 25; 24 percent ejection fraction — p=0.025
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- atorvastatin (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, Los Angeles
- Primary completion
- Feb 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY LVEF (Left Ventricular Ejection Fraction) |
24; 28; 25; 24 | 0.025 sig |
| PRIMARY Muscle Sympathetic Nerve Activity (by Sympathetic Microneurography) |
43; 39; 36; 38 | — |
| SECONDARY Left Ventricular End-diastolic Dimension (LVEDD) |
65; 28; 25; 24 | — |
| SECONDARY Cardiac Biomarker Level BNP |
175; 66; 107; 67 | — |
| SECONDARY High-sensitivity C-reactive Protein (hsCRP) as a Cardiac Biomarker |
1.6; 1.9; 1.9; 3.4 | — |
| SECONDARY Cardiac Troponin I (cTnI) |
8; 21; 0; 15 | — |
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 heart's pumping ability 2) improve functioning of the sympathetic nervous system and 3) decrease immune activation in heart failure.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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 150 U/ L, known hypersensitivity
- Likely to receive heart transplant within 3 months
- Known peripheral or autonomic neuropathy
Data sourced from ClinicalTrials.gov (NCT00233480). 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.