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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:
Information provided by (Responsible Party):
mark munger, University of Utah
ClinicalTrials.gov Identifier:
NCT00769210
First received: December 22, 2007
Last updated: March 29, 2016
Last verified: March 2016
  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
Phase 0

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: December 22, 2007
Last Updated: March 29, 2016
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on December 02, 2016