席尔德纳菲尔与安慰剂用于早期肺血管疾病的硬皮病 (SEPVADIS):随机对照试验的协议
Matthew R Lammi1,2,3,4, Monica Mukherjee5, Lesley Ann Saketkoo6,7
1Louisiana State University Health Sciences, 1901 Perdido St, 70112, New Orleans, LA,, USA. mlammi2@jh.edu.
BMC pulmonary medicine
|April 30, 2024
概括
这项研究调查了在全身性硬化症患者中治疗轻度肺高血压的西尔代纳菲尔. 结果将指导未来对治疗这种疾病的试验.
科学领域:
- 心脏病学 心脏病学
- 类风湿病学 类风湿病学
- 肺部病理学 肺部病理学
背景情况:
- 肺高血压 (PH) 是系统性硬化症 (SSc) 患者死亡的重要原因.
- 早期发现和治疗PH对于SSc管理至关重要.
- 已经降低了PH的诊断值,识别了轻微升高的肺动脉压力 (SSc-MEP) 的患者.
研究的目的:
- 评估在SSc患者中西尔代纳菲尔的疗效,患者肺动脉压略升 (mPAP 21-24 mmHg).
- 为了确定PH特异性疗法在这个患者亚组中是否有益.
主要方法:
- SEPVADIS试验是一项随机,双盲,安慰剂控制的第二阶段研究.
- 30名SSc-MEP患者将从两个美国学术网站注册.
- 主要结局:16周6分钟步行距离的变化. 二次结局包括肺动脉顺应和右心室功能.
主要成果:
- 本节不适用,因为该研究正在进行中,结果尚未提供.
结论:
- SEPVADIS试验是第一次在SSc-MEP患者中随机对西尔代纳菲尔进行研究.
- 结果将为第三阶段研究提供信息,以评估西尔德纳菲尔在治疗SSc中轻度肺高血压的疗效.
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