COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Effect of Rosuvastatin on Left Ventricular Remodeling

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00505154
Recruitment Status : Completed
First Posted : July 23, 2007
Last Update Posted : January 27, 2014
Information provided by (Responsible Party):
Lars Gullestad, Rikshospitalet University Hospital

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.

Condition or disease Intervention/treatment Phase
Dilated Cardiomyopathy Drug: Rosuvastatin Drug: placebo Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase III Study of the Effect of Rosuvastatin on Left Ventricular Remodeling and Inflammatory Markers in Heart Failure
Study Start Date : July 2007
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Arm Intervention/treatment
Placebo Comparator: 2
Placebo tablets
Drug: placebo

Active Comparator: 1
Drug: Rosuvastatin
Rosuvastatin 10 mg tablets od for 6 months

Primary Outcome Measures :
  1. End points will be LV end systolic and diastolic volume (LVESV, LVEDV), and LV-ejection fraction (LV-EF). [ Time Frame: 2009 ]

Secondary Outcome Measures :
  1. the B-type natriuretic peptide (BNP), Effect on immunological variables [ Time Frame: 2009 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00505154

Layout table for location information
Oslo University Hospital
Oslo, Norway
Sponsors and Collaborators
Oslo University Hospital
Layout table for investigator information
Study Director: Geir Gokstad Rikshospitalet, Oslo, Norway
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Lars Gullestad, Professor, Rikshospitalet University Hospital Identifier: NCT00505154    
Other Study ID Numbers: LG012007
First Posted: July 23, 2007    Key Record Dates
Last Update Posted: January 27, 2014
Last Verified: January 2014
Keywords provided by Lars Gullestad, Rikshospitalet University Hospital:
Heart failure
Additional relevant MeSH terms:
Layout table for MeSH terms
Cardiomyopathy, Dilated
Ventricular Remodeling
Heart Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors