EUCTR2017-001341-27-DK进行中（未招募）1 期
Empagliflozin in heart failure patients with reduced ejection fraction:A randomized clinical trial (Empire HF)
Morten Schou0 个研究点目标入组 190 人开始时间: 2017年4月10日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 190
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •(1) Optimal Heart Failure Therapy in accordance with European and National Guidelines
- •(3) LVEF = 0.40
- •(4) eGFR > 30 ml/min/1.73 m2
- •(5) BMI < 45 kg/m2
- •(6) NYHA class I-III
- •(7) Age > 18 years
- •(8) If T2D – optimal treatment in accordance with European and National Guidelines
- •(9) If T2D – stable doses of antiglycemic treatment for 30 days
- •(10) If T2D – HbA1C 6.5-10 %
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 57
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 133
排除标准
- •(1) CRT-D/-P implanted < 90 days
- •(2) Uncorrected severe valvular disease
- •(3) Non-compliance
- •(4) Use of metalozone
- •(5) NYHA IV
- •(6) Age > 85 years
- •(7) Dementia
- •(8) Admission for HF < 30 days
- •(9) Admission for hypoglycemia < 12 month
- •(10) Known sustained VT
- •(11) Symptomatic hypotension and systolic BP < 95 mmHg
- •(12) Unable to perform an exercise test
- •(13) Immobilization
- •(14) Pregnancy
- •(15) Participation in other medical trials
- •(16) Previous intolerance of Empagliflozin or excipients
研究者
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