Effect of Rosuvastatin on Left Ventricular Remodeling

Sponsor

Oslo University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00505154

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

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 :

Jul 1, 2007

Actual Primary Completion Date :

Jul 1, 2013

Actual Study Completion Date :

Jul 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: 2 Placebo tablets	Drug: placebo placebo
Active Comparator: 1 rosuvastatin	Drug: Rosuvastatin Rosuvastatin 10 mg tablets od for 6 months

Arm

Intervention/Treatment

Placebo Comparator: 2

Placebo tablets

Drug: placebo

placebo

Active Comparator: 1

rosuvastatin

Drug: Rosuvastatin

Rosuvastatin 10 mg tablets od for 6 months

Outcome Measures

Primary Outcome Measures

End points will be LV end systolic and diastolic volume (LVESV, LVEDV), and LV-ejection fraction (LV-EF). [2009]

Secondary Outcome Measures

the B-type natriuretic peptide (BNP), Effect on immunological variables [2009]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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