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Sponsored by: |
Rikshospitalet University Hospital |
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Information provided by: | Rikshospitalet University Hospital |
ClinicalTrials.gov Identifier: | NCT00505154 |
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 |
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Dilated Cardiomyopathy |
Drug: Rosuvastatin Drug: placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Phase III Study of the Effect of Rosuvastatin on Left Ventricular Remodeling and Inflammatory Markers in Heart Failure |
Estimated Enrollment: | 75 |
Study Start Date: | July 2007 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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2: Placebo Comparator
Placebo tablets
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Drug: placebo
placebo
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1: Active Comparator
rosuvastatin
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Drug: Rosuvastatin
Rosuvastatin 10 mg tablets od for 6 months
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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.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contraindication against statin therapy
Contact: Lars Gullestad, MD, PhD | +4723070000 | lars.gullestad@medisin.uio.no |
Norway | |
Rikshospitalet University Hospital | Recruiting |
Oslo, Norway | |
Contact: Lars Gullestad, MD, PhD +4723070000 lars.gullestad@medisin.uio.no | |
Principal Investigator: Lars Gullestad, MD, PhD |
Study Director: | Geir Gokstad | Rikshospitalet, Oslo, Norway |
Responsible Party: | Lars Gullestad ( Rikshospitalet University Hospital ) |
Study ID Numbers: | LG012007 |
Study First Received: | July 20, 2007 |
Last Updated: | August 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00505154 |
Health Authority: | Norway: The National Committees for Research Ethics in Norway |
Heart failure inflammation cytokines |
Heart Failure Rosuvastatin Heart Diseases Cardiomyopathy, Dilated |
Dilated cardiomyopathy Cardiomegaly Cardiomyopathies Inflammation |
Antimetabolites Molecular Mechanisms of Pharmacological Action Therapeutic Uses Antilipemic Agents Enzyme Inhibitors |
Cardiovascular Diseases Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions |