Effect of Rosuvastatin on Left Ventricular Remodeling

Dilated Cardiomyopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00505154
• Other study ID #: LG012007
• Status: Completed
• Phase: Phase 3
• First received: July 20, 2007
• Last updated: January 24, 2014
• Start date: July 2007
• Est. completion date: July 2013

Study information

• Verified date: January 2014
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Dilated
• Dilated Cardiomyopathy
• Ventricular Remodeling

Intervention

Drug:
• Rosuvastatin
Rosuvastatin 10 mg tablets od for 6 months
• placebo
placebo

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	End points will be LV end systolic and diastolic volume (LVESV, LVEDV), and LV-ejection fraction (LV-EF).		2009	Yes
Secondary	the B-type natriuretic peptide (BNP), Effect on immunological variables		2009	Yes