Brief Title
Effect of Rosuvastatin on Left Ventricular Remodeling
Official Title
A Phase III Study of the Effect of Rosuvastatin on Left Ventricular Remodeling and Inflammatory Markers in Heart Failure
Brief Summary
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
- 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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
End points will be LV end systolic and diastolic volume (LVESV, LVEDV), and LV-ejection fraction (LV-EF).
Secondary Outcome
the B-type natriuretic peptide (BNP), Effect on immunological variables
Condition
Dilated Cardiomyopathy
Intervention
Rosuvastatin
Study Arms / Comparison Groups
2
Description: Placebo tablets
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
75
Start Date
July 2007
Completion Date
July 2013
Primary Completion Date
July 2013
Eligibility Criteria
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
Gender
All
Ages
18 Years - 80 Years
Accepts Healthy Volunteers
No
Contacts
Geir Gokstad, ,
Location Countries
Norway
Location Countries
Norway
Administrative Informations
NCT ID
NCT00505154
Organization ID
LG012007
Responsible Party
Principal Investigator
Study Sponsor
Oslo University Hospital
Study Sponsor
Geir Gokstad, Study Director, Rikshospitalet, Oslo, Norway
Verification Date
January 2014