Effect of Rosuvastatin on Left Ventricular Remodeling
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by Rikshospitalet University Hospital.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Rikshospitalet University Hospital
Information provided by:
Rikshospitalet University Hospital
ClinicalTrials.gov Identifier:
NCT00505154
First received: July 20, 2007
Last updated: August 18, 2008
Last verified: August 2008
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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 Rikshospitalet 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 ]
| 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 |
|---|---|
|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00505154
Contacts
| Contact: Lars Gullestad, MD, PhD | +4723070000 | lars.gullestad@medisin.uio.no |
Locations
| Norway | |
| Rikshospitalet University Hospital | Recruiting |
| Oslo, Norway | |
| Contact: Lars Gullestad, MD, PhD +4723070000 lars.gullestad@medisin.uio.no | |
| Principal Investigator: Lars Gullestad, MD, PhD | |
Sponsors and Collaborators
Rikshospitalet University Hospital
Investigators
| Study Director: | Geir Gokstad | Rikshospitalet, Oslo, Norway |
More Information
No publications provided
| Responsible Party: | Rikshospitalet University Hospital, Lars Gullestad |
| ClinicalTrials.gov Identifier: | NCT00505154 History of Changes |
| Other Study ID Numbers: | LG012007 |
| Study First Received: | July 20, 2007 |
| Last Updated: | August 18, 2008 |
| Health Authority: | Norway:National Committee for Medical and Health Research Ethics |
Keywords provided by Rikshospitalet University Hospital:
|
Heart failure inflammation cytokines |
Additional relevant MeSH terms:
|
Cardiomyopathy, Dilated Heart Failure Ventricular Remodeling Cardiomyopathies Cardiomegaly Heart Diseases Cardiovascular Diseases Pathological Conditions, Anatomical Rosuvastatin |
Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Enzyme Inhibitors Lipid Regulating Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013