Prospective, Randomized, Controlled Trial of the Effect of Long-term Oxygen Therapy on 6-minute Walking Distance, Clinical Parameters and Hemodynamics in Patients With PAH and CTEPH
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- 6-minute Walking distance
研究概览
简要总结
Treatment of O2 naïve patients with PAH will be included in this investigator-initiated trial (IIT) to assess efficacy and safety of oxygen substitution. Nocturnal oxygen substitution improved the 6MWD compared to placebo in one clinical trial in PAH patients. Due to the positive results in the treatment of patients with PAH, the initiation of this proof-of-concept study is justified.
详细描述
Most patients with PAH, except those with congenital heart defects and pulmonary-to-systemic shunts, have minor degrees of hypoxemia at rest and during the night.Current recommendations including the pneumological guidelines for LTOT are based on evidence in patients with chronic obstructive pulmonary disease, as data for patients with PH are lacking: When O2 partial pressure is repeatedly <8 kPa (<60 mmHg, alternatively, 90% of O2 saturation), patients are advised to use O2 to achieve a saturation of >8 kPa. The use of ambulatory O2 can be considered when there is evidence of a symptomatic response or correction of exercise-induced desaturation.
There are only few studies investigating the effect of oxygen supply in pulmonary hypertension, most of which merely investigate acute effects of O2 administration. Short-term oxygen administration has been shown to reduce mean pulmonary arterial pressure, pulmonary vascular resistance and to increase cardiac output in PAH patients. In one study, oxygen supply also reversed the progression of PH in patients with chronic obstructive pulmonary disease (COPD). One recent randomized-controlled trial indicates that O2 given during cardiopulmonary exercise significantly improves maximal work rate and endurance. Furthermore, nocturnal oxygen supply for one week significantly improved 6-minute walking distance in patients with PH, sleep-associated breathing difficulties, exercise performance during the day as well as cardiac repolarisation. Patients with Eisenmenger's syndrome gain little benefit from nocturnal O2 therapy.
Whether these positive effects of O2 supplementation during exercise would translate into long-term improvements of exercise capacity, quality of life, hemodynamics and disease progression is not known to date. Up to now, there are no randomised studies suggesting that long-term O2 therapy is indicated or when it should be initiated.
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
- None
盲法说明
PAH patients experiencing oxygen desaturations at rest and during physical activity, when O2 partial pressure is repeatedly <8 kPa (<60 mmHg; alternatively, 90% of O2 saturation). Patients will be divided in a supplemental-oxygen group (primary intervention group) and no-supplemental-oxygen group (control group). Patients of the control group will be offered to participate in the interventional treatment arm after they have terminated the control period (partial cross-over; secondary intervention group). Randomization will be performed in a 1:1 ratio. Randomization to one of the groups will be performed by block randomization. Randomization lists will be created by the data management using a computer to generate random numbers.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Oxygen Therapy provided
Patients will be divided in a supplemental-oxygen group (primary intervention group) throughout the study
干预措施: Oxygen (Drug)
no-supplemental-oxygen group (control group)
Patients of the control group will beginn the study without Oxygen Therapie and will be offered to participate in the interventional treatment arm after they have terminated the control period (partial cross-over; secondary intervention group).
干预措施: Oxygen (Drug)
结局指标
主要结局
6-minute Walking distance
时间窗: Change from baseline to 6 months
To determine the benefits for PH patients from a long-term oxygen therapy (LTOT) given continuously during ≥16h/day for 12 weeks, measured by improvement of exercise performance assessed by the 6 minute walking distance (6MWD).
次要结局
- Oxygen pulse(Change from baseline to 6 months)
- pulmonary vascular resistance (PVR)(Change from baseline to 6 months)
- cardiac index in liters per minute per square meter (of body surface area) /(CI)(Change from baseline to 6 months)
- blood gas analysis from pulmonary artery(Change from baseline to 6 months)
- Change in systolic pulmonary arterial pressure(Change from baseline to 6 months)
- Echocardiography and Stress Doppler Echocardiography(Change from baseline to 6 months)
- Quality of life: mental Summation score; short form health Survey 36 (score from 0-100; higher scores indicating better outcome)(Change from baseline to 6 months)
- mean pulmonary arterial pressure(Change from baseline to 6 months)
- pulmonary arterial wedge pressure(Change from baseline to 6 months)
- cardiac output and ejection fraction (CO, HZV)(Change from baseline to 6 months)
- Peak oxygen consumption(Change from baseline to 6 months)
- oxygen Saturation(Change from baseline to 6 months)
- oxygen equivalent(Change from baseline to 6 months)
- Cardiopulmonary exercise testing(Change from baseline to 6 months)
- right atrial pressure(Change from baseline to 6 months)
- cardiac index (CI)(Change from baseline to 6 months)
- respiratory reserve(Change from baseline to 6 months)
- Peak oxygen consumption/kg body weight(Change from baseline to 6 months)
- Quality of life: physical Summation score; short form health Survey 36 (score from 0-100; higher scores indicating better outcome)(Change from baseline to 6 months)
- Clinical worsening; frequency and type of clinical worsening events(clinical worsening events from baseline to 6 months)
- systolic pulmonary arterial pressure(Change from baseline to 6 months)
- ventilatory threshold(Change from baseline to 6 months)
- World Health Organization functional classification(Change from baseline to 6 months)
研究者
Prof. Dr. med. Ekkehard Gruenig
Prof. Dr. med. Ekkehard Grünig; Head of centre for pulmonary hypertension
Thoraxklinik-Heidelberg gGmbH