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

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Utah
• Treatments: Simvastatin

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