Statin Therapy in Heart Failure: Potential Mechanisms of Benefit

NCT00233480

Last updated date
Study Location
Ahmanson-UCLA Cardiomyopathy Center
Los Angeles, California, 90095, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Congestive Heart Failure
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Advanced Information
Descriptive Information
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
  • Drug: atorvastatin
    atorvastatin 10mg PO QD
    Other Name: lipitor
  • Drug: placebo
    matched placebo Qd x 3 months
Study Arms  ICMJE
  • Experimental: active treatment
    atorvastatin 10mg QD x 3 months
    Intervention: Drug: atorvastatin
  • Placebo Comparator: placebo
    matched placebo QD x 3 months
    Intervention: Drug: placebo
Publications *

*   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
 (submitted: March 29, 2012)
27
Original Enrollment  ICMJE
 (submitted: October 4, 2005)
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:

  • 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<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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
  • Pfizer
  • National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator:Tamara B Horwich, MDUCLA Division of Cardiology
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