Status:
COMPLETED
The Effect of Simvastatin Therapy on the Expression of Procoagulant and Inflammatory Markers in Heart Failure
Lead Sponsor:
University of Utah
Conditions:
Heart Failure
Eligibility:
All Genders
18-85 years
Phase:
EARLY_PHASE1
Brief Summary
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 t...
Detailed Description
Heart failure is a significant public health problem in the United States. There are more than five million heart failure patients in America and this number grows by over 550,000 new cases each year....
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00769210
Start Date
May 1 2005
End Date
July 1 2008
Last Update
March 31 2016
Active Locations (1)
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1
University of Utah
Salt Lake City, Utah, United States, 84112