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
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