DRKS00028924已完成Unknown
Intraindividual Cardiopulmonal Adaptation to hypobaric hypoxia while long-distance flight Simulation in PH-patients - ICAROS-PH
niklinik Köln0 个研究点目标入组 41 人开始时间: 2024年3月14日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 41
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Signed informed consent form
- •- Clinically stable disease for more than 3 months, assessed by the investigator
- •- Right heart catheterisation with assessment of intracardiac blood pressure and haemodynamics within the last 24 months with PAPmean = 20 mmHg
- •- Pulmonary hypertension with stable specific therapy for at least 4 weeks (Nice Class I), or pulmonary hypertension with left heart disease (Nice Class II), or chronic thromboembolic pulmonary hypertension (Nice Class IV)
排除标准
- •- Hospitalisation due to cardiac decompensation within the last 3 months
- •- Planned PTCA, ICD implantation, ACVB surgery within the next 90 days
- •- Previous PTCA, cerebrovascular event (TIA, stroke) within the last 90 days
- •- Hb < 8 g/dl
- •- Resting PaO2 =7.3 kPA with LTOT therapy > 16 h/day (nocturnal oxygen administration permitted)
- •- Chronic pleural effusion
- •- Acute infectious disease, especially respiratory disease
- •- Women who are pregnant or breastfeeding
- •- Inability to follow the study procedures, e.g. due to speech problems, mental disorders, neurological or orthopaedic problems
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