Effect of Rosuvastatin on Left Ventricular Remodeling

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 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

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