NCT06489691已完成不适用
Comparative Study of 6-minute Walk Distance (6MWD) in Patients With High Altitude Pulmonary Hypertension Permanently Residing Above 2500 Meters When Assessed Near Resident High Altitude (HA) at 3200m vs. at Low Altitude (LA) 760m
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- 6-minute walk distance (6MWD) on day 2 of relocation to 760 m
研究概览
简要总结
To study the effect of relocation from 3200m (Aksay) to 760m (Bishkek) in highlanders with High Altitude Pulmonary Hypertension (HAPH) who permanently live >2500m on 6-minute walk distance (6MWD)
详细描述
This research in highlanders with HAPH diagnosed by echocardiography and defined by a RV/RA >30 mmHg who permanently live at HA >2500 m will perform a 6-minute walk distance test near their living altitude in Aksay at 3200 m and on day 2 and 7 at 760 m after relocation
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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) on day 2 of relocation to 760 m
时间窗: day 2 at 760 m compared to 3200 m
Change in 6MWD in meter between LA (760 m) vs HA (3200 m)
次要结局
- Arterial oxygen saturation by pulseoximetry (SpO2) at rest and at peak 6MWD on day 2 of relocation to 760 m(day 2 at 760 m compared to 3200 m)
- Heart rate at rest and at peak 6MWD on day 2 of relocation to 760 m(after the first night at LA (760 m))
- Arterial oxygen saturation by pulseoximetry (SpO2) at rest and at peak 6MWD on day 7 of relocation to 760 m(day 7 at 760 m compared to 3200 m)
- Borg leg fatigue scale at end 6MWT on day 2 of relocation to 760 m(day 2 at 760 m compared to 3200 m)
- Borg leg fatigue scale at end 6MWT on day 7 of relocation to 760 m(day 7 at 760 m compared to 3200 m)
- Blood pressure at rest and at 6MWD on day 7 of relocation to 760 m(day 7 at 760 m compared to 3200 m)
- Borg Dyspnea scale at end 6MWT on day 7 of relocation to 760 m(day 7 at 760 m compared to 3200 m)
- Blood pressure at rest and at 6MWD on day 2 of relocation to 760 m(day 2 at 760 m compared to 3200 m)
- Borg Dyspnea scale at end 6MWT on day 2 of relocation to 760 m(day 2 at 760 m compared to 3200 m)
- 6-minute walk distance (6MWD) on day 7 of relocation to 760 m(day 7 at 760 m compared to 3200 m)
- Heart rate at rest and at peak 6MWD on day 7 of relocation to 760 m(day 7 at 760 m compared to 3200 m)
研究者
研究点 (1)
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