Effect of Supplemental Oxygen Therapy (SOT) on 6-minute Walk Distance (6MWD) in Highlanders With High Altitude Pulmonary Hypertension Permanently Living at >2500m

University of Zurich1 个研究点分布在 1 个国家目标入组 24 人2024年7月1日

适应症High Altitude Pulmonary Hypertension

概览

阶段: 不适用
干预措施: 未指定
疾病 / 适应症: High Altitude Pulmonary Hypertension
发起方: University of Zurich
入组人数: 24
试验地点: 1
主要终点: 6-minute walk distance (6MWD) with SOT vs. ambient air at 3200 m
状态: 已完成
最后更新: 3个月前

概览研究者入排标准结局指标研究点相似试验

概览

简要总结

The investigators aim to study the effect of SOT in highlanders with high altitude pulmonary hypertension (HAPH) who permanently live >2500m on 6-minute walk distance (6MWD) assessed at 3200m.

详细描述

Highlanders with HAPH diagnosed by echocardiography and defined by a RV/RA (Tricuspid Regurgitation Pressure Gradient) \>30 mmHg will be recruited for this project. Highlanders permanently living at HA \>2500 m will perform a 6-minute walk distance test near their living altitude in Aksay at 3200 m with and without portable pulsed supplemental oxygen therapy (SOT) via nasal cannula according to a randomized cross-over design.

注册库

clinicaltrials.gov

开始日期

2024年7月1日

结束日期

2024年7月12日

最后更新

3个月前

研究类型

Interventional

研究设计

Crossover

性别

All

研究者

发起方

University of Zurich

责任方

Sponsor

入排标准

入选标准

•Permanently living \>2500 m
•HAPH diagnosed with a minimum RV/RA of 30 mmHg assessed by echocardiography at an altitude of 3200 m
•Written informed consent

排除标准

•Highlanders who cannot follow the study investigations,
•Patients with moderate to severe concomitant lung disease (FEV1\<70% or forced vital capacity \<70%), severe parenchymal lung disease, heavy smoking \>20 cigarettes/day or \>20 pack-years.
•Coexistent unstable systemic hypertension or coronary artery disease that required adjustment of medication within the last 2 months
•Regular use of medication that affects control of breathing (benzodiazepines, opioids, acetazolamide)

结局指标

主要结局

6-minute walk distance (6MWD) with SOT vs. ambient air at 3200 m

时间窗: after 6 minute

Change in 6MWD in meters between SOT vs. ambient air at 3200 m

次要结局

Borg leg fatigue scale at end 6MWT with SOT vs. ambient air at 3200 m(after 6 minute)
Blood pressure at rest and end 6MWT with SOT vs. ambient air at 3200 m(after 6 minute)
Borg Dyspnea scale at end 6MWT with SOT vs. ambient air at 3200 m(after 6 minute)
SpO2 at rest and end 6MWT with SOT vs. ambient air at 3200 m(after 6 minute)
Heart rate at rest and end 6MWT with SOT vs. ambient air at 3200 m(after 6 minute)