A Phase III Study of the Effect of Rosuvastatin on Left Ventricular Remodeling and Inflammatory Markers in Heart Failure
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- End points will be LV end systolic and diastolic volume (LVESV, LVEDV), and LV-ejection fraction (LV-EF).
研究概览
简要总结
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.
详细描述
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
2
Placebo tablets
干预措施: placebo (Drug)
1
rosuvastatin
干预措施: Rosuvastatin (Drug)
结局指标
主要结局
End points will be LV end systolic and diastolic volume (LVESV, LVEDV), and LV-ejection fraction (LV-EF).
时间窗: 2009
次要结局
- the B-type natriuretic peptide (BNP), Effect on immunological variables(2009)
研究者
Lars Gullestad
Professor
Rikshospitalet University Hospital