A Large Scale Clinical Trial Testing the Effects of n-3 PUFA and Rosuvastatin on Mortality-Morbidity of Patients With Symptomatic Congestive Heart Failure
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6,975
- 试验地点
- 281
- 主要终点
- All-cause mortality
研究概览
简要总结
INTRODUCTION While pharmacological treatments specifically targeted to the cardio-circulatory system have been largely investigated, scanty controlled data are available concerning the role of dietary and metabolic approaches in the management/outcome of patients with heart failure. A large scale, randomized, clinical trial is proposed to test the effects of (a) n-3 PUFA and (b) a lipid lowering agent on top of the best recommended treatments for heart failure.
STUDY DESIGN
The GISSI-HF is a prospective, multicenter, randomized, double blind, placebo controlled study, with randomized allocation of patients with a clinical diagnosis of heart failure to:
Randomization 1 (R1): n-3 PUFA 1 g daily vs corresponding placebo; Randomization 2 (R2): rosuvastatin 10 mg daily vs corresponding placebo.
OBJECTIVES OF THE STUDY PRIMARY OBJECTIVES
To demonstrate that, in patients with heart failure treated at the best of recommended therapies, long term administration of (a) n-3 PUFA, (b) rosuvastatin is more effective than the corresponding placebo in the reduction of:
- All-cause mortality
- All-cause mortality or hospitalizations for cardiovascular reason
OTHER END-POINT MEASURES OF EFFICACY
To assess that long term administration of (a) n-3 PUFA, (b) rosuvastatin is more effective than corresponding placebo in the reduction of:
- Cardiovascular mortality
- Cardiovascular mortality or hospitalizations for any reason
- Sudden cardiac death
- Hospitalizations for any reason
- Hospitalizations for cardiovascular reasons
- Hospitalizations for congestive heart failure
- Myocardial infarction
- Stroke
详细描述
The Protocol is sponsored by an independent organization and partially supported by: AstraZeneca, Società Prodotti antibiotici, Sigma Tau, Pfizer
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical evidence of heart failure according to the European Society of Cardiology guidelines (New York Heart Association class II-IV) (32)
- •Any left ventricular Ejection Fraction (EF) measured within 3 months from enrolment (if EF% >40%, at least 1 hospital admission for Congestive Heart Failure(CHF) in the previous year)
- •No age limits
- •Any etiology
- •Informed consent (obtained before any study specific procedure)
排除标准
- •COMMON EXCLUSION CRITERIA (R1=n-3 PUFA vs placebo and R2=rosuvastatin vs placebo):
- •Acute Myocardial Infarction, unstable angina or revascularization procedure within 1 month;
- •planned cardiac surgery, expected to be performed within 3 months;
- •congenital or primary valvular etiology;
- •known hypersensitivity to study treatments;
- •significant liver disease;
- •pregnant or lactating women or women of childbearing potential who are not protected from pregnancy by an accepted method of contraception;
- •any condition that in the opinion of the investigator would jeopardize the evaluation of efficacy or safety or be associated with poor adherence to the protocol;
- •presence of any non-cardiac disease (e.g. cancer) that is likely to significantly shorten life expectancy;
- •treatment with any investigational agent within 1 month before randomization;
- •patients already on treatment with n-3 PUFA or statin for whom the prescription is confirmed.
- •EXCLUSION CRITERIA FOR R2 (statin hypothesis):
- •current serum creatinine level >2.5 mg/dL;
- •current ALT, AST level >1.5 times the upper normal limit;
- •current CPK upper normal limits.
研究组 & 干预措施
1
N-3PUFA
干预措施: n-3 PUFA (Drug)
2
干预措施: Placebo (Drug)
3
Rosuvastatin
干预措施: Rosuvastatin (Drug)
4
干预措施: Placebo (Drug)
结局指标
主要结局
All-cause mortality
时间窗: from enrollment to 1252 deaths in R2 arm
All cause mortality or hospitalizations for any reason
时间窗: from enrollment to 1252 deaths
次要结局
- Miocardial infarction(from enrollment to 1252 deaths in R2 arm)
- Hospitalization for congestive heart failure(from enrollment to 1252 deaths in R2 arm)
- Cardiovascular mortality(from enrollment to 1252 deaths in R2 arm)
- Cardiovascular mortality or hospitalization for heart failure or for any reasons(from enrollment to 1252 deaths in R2 arm)
- Sudden cardiac death(from enrollment to 1252 deaths in R2 arm)
- Hospitalizations for any reasons(from enrollment to 1252 deaths in R2 arm)
- Hospitalization for Cardiovascular reasons(from enrollment to 1252 deaths in R2 arm)
- Stroke(from enrollment to 1252 deaths in R2 arm)