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临床试验/EUCTR2016-004291-21-AT
EUCTR2016-004291-21-AT进行中(未招募)1 期

Effect of phosphodiesterase-5 inhibition with Tadalafil on SystEmic RightVEntricular size and function – a multi-center, double-blind, randomized,placebo-controlled clinical trial – SERVE Trial - SERVE

Insel Gruppe AG - Inselspital Universitätsklinik für Kardiologie0 个研究点目标入组 98 人开始时间: 2017年12月5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
98

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

  • Adults (=18 years) with a systemic RV due to due to D-TGA repaired with an atrial switch procedure or due to ccTGA
  • 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 98
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • No informed consent; myocardial infarction, stroke, or open heart
  • surgery in the previous 3 months; expected heart
  • transplant within the next 6 months; pregnant or nursing women;
  • severe renal insufficiency; hypersensitivity to
  • Tadalafil; known allergy to iodinated or Gadolinium-based contrast

研究者

发起方
Insel Gruppe AG - Inselspital Universitätsklinik für Kardiologie

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