NCT06489704已完成不适用
Comparative Study of Pulmonary Artery Pressure (PAP) Assessed by Echocardiography in Patients With High Altitude Pulmonary Hypertension (HAPH) Permanently Residing Above 2500 Meters When Assessed Near Resident High Altitude (HA) at 3200 m vs. at Low Altitude (LA) at 760 m
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
- Change in Pulmonary artery Pressure (PAP) after the first night at 760 m (LA) vs at 3200 m (HA)
研究概览
简要总结
To study the effect of relocation from 3200 m (Aksay) to 760 m (Bishkek) in patients with high altitude pulmonary hypertension (HAPH) who permanently live >2500 m on pulmonary artery pressure (PAP)
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 have pulmonary arterial pressure (PAP) assessed by echocardiography near their living altitude in Aksay at 3200 m and at 760 m in Bishkek the day after the first and the seventh night 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
Change in Pulmonary artery Pressure (PAP) after the first night at 760 m (LA) vs at 3200 m (HA)
时间窗: day 2 at 760 m vs. 3200 m
Change in RV/RA in mmHg assessed by echocardiography between LA (760 m) vs High altitude (3200 m)
次要结局
- Tricuspid pressure gradient by echocardiography at 760 m (LA) vs at 3200 m (HA)(day 2 and 7 at 760 m vs. 3200 m)
- Change in right to left heart diameter ratio at 760 m (LA) vs at 3200 m (HA)(day 2 and 7 at 760 m vs. 3200 m)
- Change in ECG morphology at 760 m (LA) vs at 3200 m (HA)(day 2 and 7 at 760 m vs. 3200 m)
- Change in Pulmonary artery Pressure (PAP) after seven nights at 760 m (LA) vs at 3200 m (HA)(day 7 at 760 m vs. 3200 m)
- partial pressure of oxygen (PaO2) by arterial blood gases at 760 m (LA) vs at 3200 m (HA)(day 2 and 7 at 760 m vs. 3200 m)
- Cardiac output at 760 m (LA) vs at 3200 m (HA)(day 2 and 7 at 760 m vs. 3200 m)
- Tricupsid annular plane systolic excursion by echocardiography at 760 m (LA) vs at 3200 m (HA)(day 2 and 7 at 760 m vs. 3200 m)
- partial pressure of carbon dioxide (PaCO2) by arterial blood gases at 760 m (LA) vs at 3200 m (HA)(after the first and seventh night at LA)
- Change in right heart strain at 760 m (LA) vs at 3200 m (HA)(day 2 and 7 at 760 m vs. 3200 m)
- pH by arterial blood gases at 760 m (LA) vs at 3200 m (HA)(day 2 and 7 at 760 m vs. 3200 m)
- Change in right atrial area at 760 m (LA) vs at 3200 m (HA)(day 2 and 7 at 760 m vs. 3200 m)
研究者
研究点 (1)
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