Effect of Rosuvastatin on Left Ventricular Remodeling

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oslo University Hospital
• Treatments: Rosuvastatin Calcium

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