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Completed

NCT Number: NCT00505154

Effect of Rosuvastatin on Left Ventricular Remodeling

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.

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Key information

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rosuvastatin

Drug

Rosuvastatin 10 mg tablets od for 6 months

Placebo

Drug

placebo

Primary outcomes

  1. End points will be LV end systolic and diastolic volume (LVESV, LVEDV), and LV-ejection fraction (LV-EF).

    Time frame: 2009

Secondary outcomes

  1. the B-type natriuretic peptide (BNP), Effect on immunological variables

    Time frame: 2009

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

A Phase III Study of the Effect of Rosuvastatin on Left Ventricular Remodeling and Inflammatory Markers in Heart Failure

Important dates

Study start
2007
Primary completion
2013
Study completion
2013
First posted
Jul 23, 2007
Registry last updated
Jan 27, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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