Effect of Rosuvastatin on Left Ventricular Remodeling - Full Text View

Sponsored by:	Rikshospitalet University Hospital
Information provided by:	Rikshospitalet University Hospital
ClinicalTrials.gov Identifier:	NCT00505154

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 III

MedlinePlus related topics: Cardiomyopathy Heart Failure

Drug Information available for: Rosuvastatin Rosuvastatin calcium

U.S. FDA Resources

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

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
2: Placebo Comparator Placebo tablets	Drug: placebo placebo
1: Active Comparator 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

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

Keywords provided by Rikshospitalet University Hospital:

Heart failure
inflammation
cytokines

Study placed in the following topic categories:

Heart Failure
Rosuvastatin
Heart Diseases
Cardiomyopathy, Dilated

Dilated cardiomyopathy
Cardiomegaly
Cardiomyopathies
Inflammation

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents
Enzyme Inhibitors

Cardiovascular Diseases
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009