Statin Therapy in Heart Failure: Potential Mechanisms of Benefit
NCT00233480
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- 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.
- 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
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Descriptive Information | ||||
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Brief Title ICMJE | Statin Therapy in Heart Failure: Potential Mechanisms of Benefit | |||
Official Title ICMJE | A Double-blind Randomized, Placebo-Controlled, Single-Center Study to Assess the Impact of Statins on the Autonomic Nervous System and Cardiac Structure/Function in Non-Ischemic Heart Failure | |||
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 heart's pumping ability 2) improve functioning of the sympathetic nervous system and 3) decrease immune activation in heart failure. | |||
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 statins in HF are currently underway, but these trials will not address underlying mechanisms. The aim of the study is to investigate statins' potentially beneficial mechanisms of action in HF, focusing on: 1) sympathetic nervous system activation and 2) myocardial remodeling, and 3) immune activation in heart failure. Fifty patients with systolic HF of non-ischemic etiology from a single center will be randomized in a double-blinded fashion to 3 months of atorvastatin 10mg QD (25 subjects) vs matching placebo QD (25 subjects). The following exams will be performed at baseline (pre-treatment) and at end of study (post-treatment): sympathetic microneurography, echocardiography, and peripheral blood chemokine analysis. Sympathetic microneurography at the peroneal nerve will directly quantify changes in sympathetic nerve activity (bursts/minute). Echocardiography (with the addition of MRI in a subset of subjects without pacemakers or implantable defibrillators) will be used to track changes in cardiac structure and function; indices of remodeling will include measurement of left ventricular mass index, left ventricular volume indices, left ventricular ejection fraction, and subendocardial scar quantification (MRI only). Immune activation will be characterized by circulating cytokines and chemokines. Additionally, quantification of established cardiac biomarkers (cardiac troponin, B-type natriuretic peptide, and C-reactive Protein), Holter monitor/heart rate variability studies, and quality of life and global clinical assessment will be performed pre- and post- treatment. Neither sympathetic microneurography nor MRI have been previously utilized to assess statins' effects in humans with HF. The impact of statin therapy on inflammatory chemokine activation in HF also has not been studied. The knowledge gained from our proposed investigations may serve as a basis for understanding how statin therapy has potential to improve clinical outcomes in HF, and may ultimately lead to new therapeutic strategies for HF. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | |||
Condition ICMJE | Heart Failure, Congestive | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 27 | |||
Original Enrollment ICMJE | 50 | |||
Actual Study Completion Date ICMJE | February 2009 | |||
Actual Primary Completion Date | February 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00233480 | |||
Other Study ID Numbers ICMJE | UCLA IRB #04-12-007-01 1K23HL085097-01A1 ( U.S. NIH Grant/Contract ) | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Tamara Horwich, University of California, Los Angeles | |||
Study Sponsor ICMJE | University of California, Los Angeles | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | University of California, Los Angeles | |||
Verification Date | March 2020 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |