EUCTR2020-005317-40-DK进行中(未招募)1 期
Empagliflozin to elderly and obese patients with cardiovascular disease (EMPIRE II): A randomized controlled trial
Odense University Hospital - Department of Cardiology0 个研究点目标入组 204 人开始时间: 2021年4月7日最近更新:
适应症
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
- 204
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)Age 60-84 years
- •(2) Bodymass index >28 kg/m2
- •(3) Documented risk factors for developing heart failure, i.e. one-of following :
- •(3a) Hypertension
- •(3b) Documented ischemic heart disease
- •(3c) Stroke or transitory cerebral ischemia
- •(3d) Chronic kidney disease with GFR 30-45 ml/min/1,72m2
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 104
排除标准
- •(1) Diabetes mellitus (type 1 or 2)
- •(2) Heart failure with ejection fraction <40%
- •(3) Inability to perform exercise test
- •(4) Dementia
- •(5) Non-compliance
- •(6) Substance abuse
- •(7) GFR <30 ml/min/1,72m2
- •(8) Severe chronic obstructive pulmonary disease (FEV1< 50% expected value)
- •(9) Permanent atrial fibrillation
- •(10) Severe peripheral artery disease
- •(11) Cancer treatment within one year beside prostate cancer and basal cell carcinoma
- •(12) Severe aortic or mitral valve disease
- •(13) Acute hospital admission within 30 days
- •(14) Participation in other pharmacological study
- •(15) Pregnancy
- •(16) Breastfeeding
研究者
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