NCT03036124已完成3 期
Study to Evaluate the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients With Chronic Heart Failure With Reduced Ejection Fraction
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 4,744
- 试验地点
- 1
- 主要终点
- Subjects Included in the Composite Endpoint of CV Death, Hospitalization Due to Heart Failure or Urgent Visit Due to Heart Failure.
研究概览
简要总结
The purpose of this study is to evaluate the effect of dapagliflozin on the incidence of worsening heart failure or cardiovascular death in patients with chronic heart failure with reduced ejection fraction
详细描述
This is an international, multicentre, parallel group, event-driven, randomized, double-blind, placebo-controlled study in patients with chronic heart failure with reduced ejection fraction (HFrEF), evaluating the effect of dapagliflozin versus placebo, given once daily in addition to background regional standard of care therapy, for the prevention of cardiovascular (CV) death or reduction of heart failure (HF) events.
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 130 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed informed consent prior to any study specific procedures
- •Male or female, aged ≥18 years
- •Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months
- •Elevated NT-proBNP levels
- •Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines
- •eGFR ≥30 mL/min/1.73 m^2 (CKD-EPI formula) at enrolment (visit 1)
排除标准
- •Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
- •Type 1 diabetes mellitus
- •Symptomatic hypotension or systolic BP <95 mmHg at 2 out of 3 measurements either at visit 1 or visit 2
- •Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
- •MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
- •Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization
- •Implantation of a CRT within 12 weeks prior to enrolment or intent to implant a CRT device
- •Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
- •HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
- •Symptomatic bradycardia or second or third degree heart block without a pacemaker
- •Severe (eGFR <30 mL/min/1.73 m^2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization
研究组 & 干预措施
Dapagliflozin
Experimental
Patients will be randomized 1:1 to either dapagliflozin or placebo.
干预措施: Dapagliflozin (Drug)
Placebo
Placebo Comparator
Placebo matching dapagliflozin.
干预措施: Placebo (Drug)
结局指标
主要结局
Subjects Included in the Composite Endpoint of CV Death, Hospitalization Due to Heart Failure or Urgent Visit Due to Heart Failure.
时间窗: Up to 27.8 months.
Primary efficacy
次要结局
- Change From Baseline in the KCCQ Total Symptom Score(Baseline and 8 months or death before 8 months)
- Events Included in the Composite Endpoint of Recurrent Hospitalizations Due to Heart Failure and CV Death.(Up to 27.8 months.)
- Subjects Included in the Composite Endpoint of CV Death or Hospitalization Due to Heart Failure.(Up to 27.8 months.)
- Subjects Included in the Composite Endpoint of ≥50% Sustained Decline in eGFR, ESRD or Renal Death.(Up to 27.8 months.)
- Subjects Included in the Endpoint of All-cause Mortality.(Up to 27.8 months.)
研究者
研究点 (1)
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