Hemodynamic Effects of Acute Normobaric Hypoxia During Exercise in Patients With Pulmonary Hypertension: Single-center Randomized Controlled Trial
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
- Serum levels of ferritin
研究概览
简要总结
To study the effect of acute normobaric hypoxia during exercise in patients with pulmonary hypertension on blood markers (serum markers of iron and red blood cell homeostasis and micro-RNAs known to be associated with PH).
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%)
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)
Placebo-ambient air (FiO2 21%)
Inhalation of room 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: Placebo-ambient air (FiO2 21%) (Other)
Normobaric hypoxia (FiO2 15%) under Sildenafil
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%) under Sildenafil (Other)
Placebo-ambient air (FiO2 21%) under Sildenafil
Inhalation of room 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: Placebo-ambient air (FiO2 21%) under Sildenafil (Other)
结局指标
主要结局
Serum levels of ferritin
时间窗: Baseline
Analyis of serum levels of ferritin
次要结局
- Serum levels of transferrin(Baseline)
- micro-RNA levels(Baseline)
- Serum levels of total iron(Baseline)
- Serum levels of hepcidin(Baseline)
- Serum levels of erythropoietin(Baseline)
- Serum levels of Erythroferrone(Baseline)