Effect of Rosuvastatin on Left Ventricular Remodeling

Study Overview
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Brief Summary
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The purpose of this study is to examine the the effect of the HMG-CoA reductase inhibitor Rosuvastatin on left ventricular remodeling in patients with dilated cardiomyopathy.

Detailed Description
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Chronic heart failure (HF) is one of the most important public health problems in cardiovascular medicine. Idioatic dilated cardiomyopathy (CMP) represents the final common expression of primary myocardial damage produced by a variety of as yet undefined myocardial insults, producing areas of interstitial and perivascular fibrosis, particularly of the left ventricle. Chronic HF, including CMP, is a progressive disease with high morbidity and mortality, suggesting that important pathogenic mechanisms remain active and unmodified by the present treatment modalities. The presence of chronic inflammation in patients with chronic heart failure has been widely recognized and coupled with persistent immune activation may represent such unmodified mechanisms. The effect of statin therapy on lipids are well known, but recent studies suggest that the beneficial effects of statins also may be related to their anti-inflammatory properties. To further elucidate this issue we want to study the potent new statin Rosuvastatin on myocardial function and remodeling and their relation to inflammatory markers in patients with IDCM. As hyperlipidemia is not involved in the pathogenesis of IDCM, as opposed to HF secondary to CAD, such studies will also be an interesting approach in separating the lipid lowering from other effects of these medications in HF.

Official Title
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A Phase III Study of the Effect of Rosuvastatin on Left Ventricular Remodeling and Inflammatory Markers in Heart Failure

Conditions
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Dilated Cardiomyopathy

Intervention / Treatment
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* Drug: Rosuvastatin
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age of 18-80 years Have clinical or symptomatic evidence of HF, in NYHA class II-IV, for at least 3 months Have LVEF <40% On optimal medical treatment and considered unsuitable for surgical intervention. Have given written informed consent No planned heart transplantation Female of potential childbearing age must have a negative serum pregnancy test within 7 days prior to enrollment. Effective contraception must be used during the trial and for 6 weeks following discontinuation of the study medication, even where there has been a history of infertility. Exclusion Criteria: Evidence of unstable disease Evidence of ischemic etiology on the basis of history (diagnosed myocardial infarction), echocardiography or angiography) Evidence of clinical significant valvular disease based on echocardiography Significant concomitant diseases such as infections, pulmonary disease or connective tissue disease. Contraindication against statin therapy Hypersensitivity against statins Liver disease with SGOT and SGPT > 2 timer upper normal limit Baseline elevations of CK 3 times upper normal values at any time during the course of the study Serum creatinine above 2.0 mg/dL (177 umol/L) at any time during the course of the study Pregnancy or breast feeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 2<br>Placebo tablets | Drug: placebo<br>* placebo<br>|
| Active Comparator: 1<br>rosuvastatin | Drug: Rosuvastatin<br>* Rosuvastatin 10 mg tablets od for 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| End points will be LV end systolic and diastolic volume (LVESV, LVEDV), and LV-ejection fraction (LV-EF). |  | 2009 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the B-type natriuretic peptide (BNP), Effect on immunological variables |  | 2009 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart failure, inflammation, cytokines