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临床试验/EUCTR2020-005317-40-DK
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

发起方
Odense University Hospital - Department of Cardiology

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