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The Effect of Simvastatin Therapy on the Expression of Procoagulant and Inflammatory Markers in Heart Failure

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00769210
First Posted: October 9, 2008
Last Update Posted: March 31, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
mark munger, University of Utah
  Purpose
Our proposed research will examine whether treatment with simvastatin alters expression and activity of monocyte TF, whether polymorphisms in the TF gene alter the therapeutic effect and what effect treatment has on inflammatory markers in heart failure. The results of this study may assist in tailoring statin therapy to specific characteristics, such as inflammatory state, of heart failure patients. If treatment with simvastatin significantly lowers TF expression, this may reduce the risk of thromboembolic events in patients with heart failure, thus reducing mortality and morbidity. If the treatment effect varies based on the TF genotype, this may define an identifiable population in whom statin therapy may be more beneficial than the population as a whole.

Condition Intervention Phase
Heart Failure Drug: Simvastatin Early Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Effect of Simvastatin Therapy on the Expression of Procoagulant and Inflammatory Markers in Heart Failure

Resource links provided by NLM:


Further study details as provided by mark munger, University of Utah:

Primary Outcome Measures:
  • Measure the effect of simvastatin treatment on the expression and activity of TF in patients with heart failure. [ Time Frame: May 2005-June 2008 ]

Secondary Outcome Measures:
  • Determine if polymorphisms in the gene coding for TF affect the impact of simvastatin therapy on tissue factor expression [ Time Frame: May 2005-June 2008 ]

Enrollment: 12
Study Start Date: May 2005
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: Simvastatin
Simvastatin 40 mg tablet
Other Name: Zocor

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age of 18 to 85 years
  • Symptomatic heart failure, NYHA class I to III
  • Left ventricular ejection fraction < 0.40
  • Give written informed consent

Exclusion Criteria:

  • Pregnant or lactating women. Women in reproductive years must have an active form of contraception (oral contraceptives, IUD, diaphragm, condoms or surgical sterilization) and a negative pregnancy test at study entry.
  • Heart failure as the results of any of the following conditions:

    1. active myocarditis
    2. congenital heart disease
    3. uncorrected, hemodynamically significant stenotic valvular disease
    4. NYHA functional class IV symptoms
    5. Current or previous treatment with a statin Patients with plasma LDL-C concentrations higher than 130 mg/dL and any of the following conditions
    6. Ischemic cardiomyopathy
    7. Previous cardiovascular event (CVA, ACS event)
    8. Known coronary artery disease
    9. Unstable angina
  • Presence of any progressive systemic disease that would be expected to impact the patient's outcome over the time course of the study
  • Uncorrected endocrine disorders including primary aldosteronism, pheochromocytoma, hyperthyroidism, hypothyroidism, brittle type 1 diabetes mellitus
  • Inherited disorders of lipid metabolism
  • Evidence of significant renal disease (serum creatinine > 2.5 mg/dl), or hepatic disease (transaminase levels > three fold higher than laboratory normal)
  • Inability or unwillingness to cooperate with study or give written informed consent
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00769210


Locations
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Mark Munger, PharmD University of Utah
  More Information

Responsible Party: mark munger, Professor, University of Utah
ClinicalTrials.gov Identifier: NCT00769210     History of Changes
Other Study ID Numbers: 2012064
IRB# 00013639
First Submitted: December 22, 2007
First Posted: October 9, 2008
Last Update Posted: March 31, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Simvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors