NCT06072417进行中（未招募）不适用
Comparative Study of Sleep Disordered Breathing (SDB) 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
- Mean nocturnal SpO2 at LA vs. HA
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 sleep disordered breathing
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 nocturnal respiratory sleep studies near their living altitude in Quito at 2840m and at sea level in Pedernales during 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 cigarettes/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
Mean nocturnal SpO2 at LA vs. HA
时间窗: during the first night at low altitude (of intervention)
Change in mean nocturnal SpO2 (%) between LA (sea level) vs HA (2840 m)
次要结局
- pulse transit time drops at LA vs. HA(during the first and second night at low altitude)
- Mean nocturnal SpO2 at LA vs. HA(during the second night at low altitude (of intervention))
- Time spent with SpO2<90% at LA vs. HA(during the first and second night at low altitude (of intervention))
- Heart rate variability at LA vs. HA(during the first and second night at low altitude (of intervention))
- AHI at LA vs. HA(during the first and second night at low altitude (of intervention))
- ECG markers of repolarization at LA vs. HA(during the first and second night at low altitude)
- ODI at LA vs. HA(during the first and second night at low altitude (of intervention))
- Time spent with periodic breathing at LA vs. HA(during the first and second night at low altitude (of intervention))
研究者
研究点 (2)
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