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Effect of Rosuvastatin on Left Ventricular Remodeling

Primary Purpose

Dilated Cardiomyopathy

Status
Completed
Phase
Phase 3
Locations
Norway
Study Type
Interventional
Intervention
Rosuvastatin
placebo
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dilated Cardiomyopathy focused on measuring Heart failure, inflammation, cytokines

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Oslo University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

2

1

Arm Description

Placebo tablets

rosuvastatin

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 20, 2007
Last Updated
January 24, 2014
Sponsor
Oslo University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00505154
Brief Title
Effect of Rosuvastatin on Left Ventricular Remodeling
Official Title
A Phase III Study of the Effect of Rosuvastatin on Left Ventricular Remodeling and Inflammatory Markers in Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dilated Cardiomyopathy
Keywords
Heart failure, inflammation, cytokines

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo tablets
Arm Title
1
Arm Type
Active Comparator
Arm Description
rosuvastatin
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Intervention Description
Rosuvastatin 10 mg tablets od for 6 months
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
End points will be LV end systolic and diastolic volume (LVESV, LVEDV), and LV-ejection fraction (LV-EF).
Time Frame
2009
Secondary Outcome Measure Information:
Title
the B-type natriuretic peptide (BNP), Effect on immunological variables
Time Frame
2009

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geir Gokstad
Organizational Affiliation
Rikshospitalet, Oslo, Norway
Official's Role
Study Director
Facility Information:
Facility Name
Oslo University Hospital
City
Oslo
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
24586994
Citation
Broch K, Askevold ET, Gjertsen E, Ueland T, Yndestad A, Godang K, Stueflotten W, Andreassen J, Svendsmark R, Smith HJ, Aakhus S, Aukrust P, Gullestad L. The effect of rosuvastatin on inflammation, matrix turnover and left ventricular remodeling in dilated cardiomyopathy: a randomized, controlled trial. PLoS One. 2014 Feb 25;9(2):e89732. doi: 10.1371/journal.pone.0089732. eCollection 2014.
Results Reference
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Effect of Rosuvastatin on Left Ventricular Remodeling

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