NL-OMON45523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 - DAPA HF
Astra Zeneca0 个研究点目标入组 100 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Provision of signed informed consent prior to any study specific procedures
- •2. Male or female, aged *18 years at the time of consent
- •3. Established documented diagnosis of symptomatic HFrEF
- •4. LVEF*40% within the last 12 months prior to enrolment (Visit 1)
- •5. NT-proBNP >600 pg/ml
- •6. Patients should receive background standard of care for HFrEF
- •7. eGFR *30 ml/min/1.73 m2 at visit 1
排除标准
- •1. Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
- •2. Type 1 diabetes mellitus (T1D)
- •3. Symptomatic hypotension or systolic BP <95 mmHg on 2 consecutive measurements
- •4. Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
- •5. MI, unstable angina, stroke or transient ischemic attack (TIA) within 12 weeks prior to enrolment
- •6. Coronary revascularization 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
- •7. Implantation of a cardiac CRT within 12 weeks prior to enrolment or intent to implant a CRT device
- •8. Previous cardiac transplantation or implantation of a ventricular assistance device
- •(VAD) or similar device, or implantation expected after randomization
研究者
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