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临床试验/EUCTR2019-004452-11-DE
EUCTR2019-004452-11-DE进行中(未招募)1 期

Effect of semaglutide 2.4 mg once weekly on function and symptoms in subjects with obesity-related heart failure with preserved ejection fraction - STEP-HFpEF

ovo Nordisk A/S0 个研究点目标入组 516 人开始时间: 2020年12月3日最近更新:
适应症

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
516

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

  • - Male or female, age above or equal to 18 years at the time of signing informed consent.
  • - Body mass index (BMI) equal to or above 30.0 kg/m^2
  • - New York Heart Association (NYHA) Class II-IV
  • - Left ventricular ejection fraction (LVEF) equal to or above 45 % at screening
  • 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 258
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 258

排除标准

  • - A self-reported change in body weight above 5 kg (11 lbs) within 90 days before screening irrespective of medical records
  • - Glycated haemoglobin A1c (HbA1c) equal to or above 6.5 % (48 mmol/mol) based on latest available value from medical records, no older than 3 months or if unavailable a local measurement at screening

研究者

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