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Effect of Rosuvastatin on Left Ventricular Remodeling

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lars Gullestad, Rikshospitalet University Hospital
ClinicalTrials.gov Identifier:
NCT00505154
First received: July 20, 2007
Last updated: January 24, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Dilated Cardiomyopathy
Drug: Rosuvastatin
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

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

Secondary Outcome Measures:
  • the B-type natriuretic peptide (BNP), Effect on immunological variables [ Time Frame: 2009 ] [ Designated as safety issue: Yes ]

Enrollment: 75
Study Start Date: July 2007
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 2
Placebo tablets
Drug: placebo
placebo
Active Comparator: 1
rosuvastatin
Drug: Rosuvastatin
Rosuvastatin 10 mg tablets od for 6 months

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00505154

Locations
Norway
Oslo University Hospital
Oslo, Norway
Sponsors and Collaborators
Oslo University Hospital
Investigators
Study Director: Geir Gokstad Rikshospitalet, Oslo, Norway
  More Information

No publications provided by Oslo University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lars Gullestad, Professor, Rikshospitalet University Hospital
ClinicalTrials.gov Identifier: NCT00505154     History of Changes
Other Study ID Numbers: LG012007
Study First Received: July 20, 2007
Last Updated: January 24, 2014
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Oslo University Hospital:
Heart failure
inflammation
cytokines

Additional relevant MeSH terms:
Cardiomyopathies
Cardiomyopathy, Dilated
Ventricular Remodeling
Cardiomegaly
Cardiovascular Diseases
Heart Diseases
Pathological Conditions, Anatomical
Rosuvastatin
Anticholesteremic Agents
Antimetabolites
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014