NCT04697862已完成不适用
Hemodynamic Effects of Acute Normobaric Hypoxia During Exercise in Patients With Pulmonary Hypertension: Single-center Randomized Controlled Trial
适应症
干预措施
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
- mean pulmonary artery pressure (mPAP) / cardiac output (CO)
研究概览
简要总结
To study the effect of acute normobaric hypoxia during exercise in patients with pulmonary hypertension with/without Sildenafil
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent as documented by signature (Appendix Informed Consent Form)
- •PH class I (PAH) or IV (CTEPH) diagnosed according to guidelines: mean pulmonary artery pressure >20 mmHg, pulmonary vascular resistance ≥3 wood units, pulmonary arterial wedge pressure ≤15 mmHg during baseline measures at the diagnostic right-heart catheterization
排除标准
- •resting partial pressure of oxygen <8 kilopascal at Zürich altitude on ambient air
- •exposure to an altitude >1000 m for ≥3 nights during the last 2 weeks before the study
- •inability to follow the procedures of the study
- •patients who take nitrates
- •other clinically significant concomitant end-stage disease (e.g., renal failure, hepatic dysfunction)
研究组 & 干预措施
Normobaric hypoxia (FiO2 15%) under Sildenafil
Experimental
Inhalation of deoxygenated air through an altitude simulator ("Altitrainer"), for approx. 1/2 hour. given by a facemask, first at rest and then during exercise under Sildenafil.
干预措施: Normobaric hypoxia (FiO2 15%) under Sildenafil (Other)
Normobaric hypoxia (FiO2 15%)
Experimental
Inhalation of deoxygenated air through an altitude simulator ("Altitrainer"), for approx. 1/2 hour given by a facemask, first at rest and then during exercise.
干预措施: Normobaric hypoxia (FiO2 15%) (Other)
结局指标
主要结局
mean pulmonary artery pressure (mPAP) / cardiac output (CO)
时间窗: 4 hours
Difference in mPAP/CO during exercise between tests under normoxia with/without Sildenafil
次要结局
- Differences in blood pressure(4 hours)
- Differences in heart rate(4 hours)
- Differences in cardiac output(4 hours)
- Differences in pulmonary vascular resistance(4 hours)
- Differences in pulmonary artery wedge pressure(4 hours)
- Differences in mixed venous oxygen saturation(4 hours)
- Differences in oxygen saturation(4 hours)
- Differences in mixed venous blood gases(4 hours)
- Differences in pulmonary arterial pressure(4 hours)
- Differences in right atrial pressure(4 hours)
- Differences in arterial blood gases(4 hours)
- Differences in cerebral tissue oxygenation(4 hours)
- Differences in symptoms (Borg dyspnoea)(4 hours)
- Differences in muscle tissue oxygenation(4 hours)
- Differences in symptoms (Borg leg effort)(4 hours)
研究者
研究点 (1)
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