Chronic Clinical Effect of Acetazolamide in Pulmonary Hypertension
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Difference in 6 min walk distance
研究概览
简要总结
The study seeks primarily to determine the chronic clinical effect of AZA on exercise capacity (6MWD) compared to placebo.
详细描述
Pulmonary hypertension (PH) of various etiologies causes dyspnea, impairs exercise performance and is associated with reduced quality of life (QoL) and survival. Treatment options include therapy for any underlying causes, pulmonary vasodilator drugs, oxygen and, in selected cases, pulmonary endarterectomy or lung transplantation. Unfortunately, PH specific drugs are expensive, associated with side effects and even combined pharmacological treatment is often not sufficient to achieve clinical benefits. Therefore, novel therapeutic drugs are needed. We have recently demonstrated that sleep related breathing disorders, which are common in PH patients, can be improved by both nocturnal oxygen therapy and acetazolamide (AZA). AZA is a carbonic anhydrase (CA) inhibitor that acts as a respiratory stimulant thereby improving oxygenation and possibly PH. There are even data suggesting that CA-inhibitors have a direct pulmonary vasodilator effect. However, the potential role of AZA in the treatment of PH has not been conclusively studied. Therefore, the purpose of the current project is to investigate, the chronic clinical effects of AZA in PH patients.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients undergoing right heart catheterisation (RHC) for a clinical indication and who are diagnosed with precapillary PH (mean pulmonary arterial pressure (mPAP) ≥25 mmHg, pulmonary wedge pressure (PAWP) ≤15mmHg)
- •Patients have to be in a stable condition, on the same medication for >4 weeks
排除标准
- •Patients in whom a RHC is clinically not indicated
- •pregnant women
- •PH in left heart disease or with more than mild chronic obstructive pulmonary disease or restrictive lung disease
研究组 & 干预措施
Acetazolamide
Twice a day 250 mg acetazolamide for 5 weeks
干预措施: Acetazolamide (Drug)
Placebo
Placebo capsule 250 mg (Mannitol) twice a day 5 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Difference in 6 min walk distance
时间窗: 5 weeks
At the end of both periods (AZA and Placebo)
次要结局
- daily activity(5 weeks)
- Progressive maximal ramp cardiopulmonary exercise testing(5 weeks)
- morphological and functional parameters of the heart(5 weeks)
- Trail making test (test of cognitive Performance)(5 weeks)
- cerebral and muscle tissue oxygenation(5 weeks)
- New York Heart Association functional class(5 weeks)
- Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR)(5 weeks)
- mean nocturnal oxygen Saturation during ambulatory sleep studies(5 weeks)
- 5 point test (test of cognitive Performance)(5 weeks)
- Difference of Quality of Life (QoL) assessed by the physical subscale of the living with pulmonary hypertension questionnaire (MLHF)(5 weeks)
- Short-form medical outcome questionnaire (SF-36)(5 weeks)
- N-terminal pro-brain natriuretic Peptide (NT-proBNP)(5 weeks)
- apnea/hypopnea index during ambulatory sleep studies(5 weeks)
- Stroop test of cognitive performance(5 weeks)