Effect of Acetazolamide on Right Heart Function at Rest in Lowlanders With Chronic Obstructive Pulmunary Disease (COPD) Traveling to High Altitude
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Difference in change of pulmonary artery pressure
研究概览
简要总结
The purpose of this randomized, placebo-controlled double-blind trial is to evaluate the effect of acetazolamide on right heart function at rest in lowlanders with chronic obstructive pulmonary disease (COPD) traveling to high altitude (HA) and developing early signs of altitude-illness.
详细描述
This randomized placebo-controlled, double-blind, parallel-design trial will evaluate effect of acetazolamide on right heart function in lowlanders with chronic obstructive pulmonary disease (COPD) travelling to high altitude and developping early symptoms and/or signs of impending altitude-illness. Qualifying participants will be randomized 1:1 to acetazolamide or placebo treatment during their further stay of 2 days at 3'100 m.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) An independent pharmacist will prepare identically looking active and placebo capsules labelled with secret codes. Codes will be concealed to investigators and patients until completion of data analysis.
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women, age 35-75 y, living at low altitude (<800 m).
- •COPD diagnosed according to the Global Initiative for Obstructive Lung Disease (GOLD) guidelines, FEV1 40-80% predicted, pulse oximetry
- •≥92%, PaCO2 <6 kPa, breathing ambient air at 760 m.
- •One of the following early signs and/or symptoms of impending altitudeillness identified by self-monitoring during ascent to or stay at 3100 m:
- •Pulse oximetry SpO2≤84%
- •Headache or nausea/vomiting or fatigue/weakness or dizziness/lightheadedness of at least moderate intensity
排除标准
- •COPD exacerbation, very severe COPD with hypoxemia or hypercapnia at 760 m (see above).
- •Other lung disease, relevant comorbidities (such as uncontrolled cardiovascular disease, i.e., unstable arterial hypertension, coronary artery disease; previous stroke; obesity (body mass index >35 kg/m2); internal, neurologic, rheumatologic or psychiatric disease; current heavy smoking (>20 cigarettes per day).
- •Renal failure and/or allergy to sulfonamides.
- •Patients who do not have early signs and/or signs of impending altitudeillness by self-monitoring (as defined above) at 3'100m will not be included.
研究组 & 干预措施
Acetazolamide
Acetazolamide (oral capsules @125 mg), starting dose 3 capsules (375 mg), subsequent doses 1 capsule (125 mg) in the morning, 2 capsules (250 mg) in the evening, administered in qualifying participants, during the stay at 3100 m.
干预措施: Acetazolamide (Drug)
Placebo
Placebo (oral capsules, identically looking as active drug), starting dose 3 capsules, subsequent doses
1 capsule in the morning, 2 capsules in the evening, administered in qualifying participants, during the stay at 3100 m.
干预措施: Placebo (Drug)
结局指标
主要结局
Difference in change of pulmonary artery pressure
时间窗: 3 days
Difference in change of pulmonary artery pressure (RV/RA) evaluated by echocardiography at 3100 m in the acetazolamide compared to the placebo group
次要结局
- Difference in change of pulmonary artery pressure (RV/RA) low altitude versus high altitude(3 days)
- Difference in cardiac output(3 days)
- Difference in right heart dimensions(3 days)
- Difference in right heart function(3 days)