NCT05996302进行中（未招募）不适用
Comparative Study of 6-minute Walk Distance (6MWD) in Patients With Pulmonary Vascular Diseases Permanently Residing Above 2500 Meters When Assessed Near Resident High Altitude (HA) at 2840m vs. at Low Altitude (LA) Sea Level.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- 6-minute walk distance (6MWD) after the first night at LA
研究概览
简要总结
To study the effect of relocation from 2840m (Quito) to sea level (Pedernales) in patients with pulmonary vascular diseases (PVD) defined as pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension (PH) who permanently live >2500m on 6-minute walk distance (6MWD)
详细描述
This research in patients with PVD diagnosed with precapillary PH with right heart catheterization and classified to groups 1 and 4 (PAH or CTEPH) who permanently live at HA >2500 (PVDHA) will have 6-minute walk distance near their living altitude in Quito at 2840m and at sea level in Pedernales the day after the first and the second night after relocation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 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
- •Adult patients 18-80 years old of both genders,
- •Residence > 2500m of altitude
- •diagnosed with precapillary PH (mean pulmonary artery pressure (mPAP) >20 mmHg, pulmonary artery wedge pressure (PAWP) ≤15 mmHg and pulmonary vascular resistance (PVR) ≥2 WU (wood units) by right heart catheterization) with PH being classified as PAH or CTEPH according to guidelines
- •Patients stable on therapy
- •NYHA (new york heart association) functional class I-III
- •Provided written informed consent to participate in the study.
排除标准
- •Age <18 years or >80 years
- •unstable condition
- •Patients who cannot follow the study investigations, patient permanently living < 2500m.
- •Patients with moderate to severe concomitant lung disease (FEV1<70% or forced vital capacity <70%), severe parenchymal lung disease, severe smokers (>20 igarettes/day)
- •Severely hypoxemic patients at Quito permanently have persistent SpO2 (oxygen saturation by pulseoximetry) <80% on ambient air.
- •Patients with chronic mountain sickness (Hemoglobin > 19 g/dl in women, >21 g/dl in men)
- •Patient with a non-corrected ventricular septum defect
- •Relevant concomitant other disease of the heart, kidney, liver, blood (anemia hemoglobin<11 g/dl)
结局指标
主要结局
6-minute walk distance (6MWD) after the first night at LA
时间窗: after the first night at LA (sea level)
Change in 6MWD in meter between LA (sea level) vs HA (2840 m)
次要结局
- 6-minute walk distance (6MWD) after the second night at LA(after the second night at LA (sea level))
- Blood pressure at rest and at peak 6MWD after the first night at LA(after the first night at LA (sea level))
- Arterial oxygen saturation by pulseoximetry (SpO2) at rest and at peak 6MWD after the second night at LA(after the second night at LA (sea level))
- Heart rate at rest and at peak 6MWD after the first night at LA(after the first night at LA (sea level))
- Arterial oxygen saturation by pulseoximetry (SpO2) at rest and at peak 6MWD after the first night at LA(after the first night at LA (sea level))
- Heart rate at rest and at peak 6MWD after the second night at LA(after the second night at LA (sea level))
- Blood pressure at rest and at peak 6MWD after the second night at LA(after the second night at LA (sea level))
研究者
研究点 (2)
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