The Effect of Simvastatin Therapy on the Expression of Procoagulant and Inflammatory Markers in Heart Failure - Full Text View

Sponsored by:	University of Utah
Information provided by:	University of Utah
ClinicalTrials.gov Identifier:	NCT00769210

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
Heart Failure	Drug: Simvastatin

MedlinePlus related topics: Heart Failure

Drug Information available for: Simvastatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment
Official Title:	The Effect of Simvastatin Therapy on the Expression of Procoagulant and Inflammatory Markers in Heart Failure

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
A: Experimental	Drug: Simvastatin Simvastatin 40 mg tablet

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
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:
active myocarditis
congenital heart disease
uncorrected, hemodynamically significant stenotic valvular disease
NYHA functional class IV symptoms
Current or previous treatment with a statin Patients with plasma LDL-C concentrations higher than 130 mg/dL and any of the following conditions
Ischemic cardiomyopathy
Previous cardiovascular event (CVA, ACS event)
Known coronary artery disease
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

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:	Univerisity of Utah ( University of Utah )
Study ID Numbers:	2012064, IRB# 00013639
Study First Received:	December 22, 2007
Last Updated:	October 8, 2008
ClinicalTrials.gov Identifier:	NCT00769210
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Heart Failure
Heart Diseases
Simvastatin

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents
Enzyme Inhibitors

Cardiovascular Diseases
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009