NCT04538976已完成4 期
Copd Exacerbation and Pulmonary Hypertension Trial
Chronic Obstructive Pulmonary Disease Trial Network, Denmark5 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2020年2月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 5
- 主要终点
- Time alive and out of hospital
研究概览
简要总结
This trial will investigate whether patiens admitted with an acute exacerbation of chronic obstructive lung disease and pulmonary hypertension will benefit from a targeted pharmacological treatment.
详细描述
During admittance due to acute exacerbation of chronic obstructive lung disease will patience have an echocardiography to examine their pulmonary pressure. If patient have a tricuspidal return gradient above 40 mmHg, they will receive treatment with a phosphordiesterase-5-inhibitor, Sildenafil.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •COPD verified by specialist and spirometry
- •Admitted with the diagnosis "acute exacerbation of COPD"
- •TR-gradient ≥40 mmHg verified by specialist and echocardiography
- •Informed consent
排除标准
- •Known pulmonal hypertension
- •Known heart disease which affects the pump function of the heart
- •Men <40 years
- •Women <55 years
- •Not-menopauseal women <55 years (Menopause is defined as no menstruation within 12 months.)
- •Severe mental illness which significantly complicates cooperation
- •Severe language difficulties which significantly complicates cooperation
- •known allergy to Sildenafil
- •Sildenafil consumption ≥50 mg / week due to other indications
研究组 & 干预措施
Sildenafil
Active Comparator
Patients in the Sildenafil group will receive standard care and targeted Sildenafil-treatment.
干预措施: Sildenafil (Drug)
结局指标
主要结局
Time alive and out of hospital
时间窗: 365 days
次要结局
- Death within 1 year(365 days)
- Number of days with non-invasive ventilation (NIV) or respirator during admittance(14 days)
- Delta Pa(O2)(4 days)
- Time to "prednisolon and/or antibiotica"-needing exacerbation of COPD or death(365 days)
- Death within 90 days(90 days)
- Clinical cure(14 days)
- Delta(pH)(4 days)
- Alive and without exacerbation of COPD on day 365(365 days)
- Number of readmissions due to exacerbations of COPD(365 days)
- Delta Pa(CO2)(4 days)
- Change in FEV1(90 days)
- Change in Body Mass Index (BMI)(90 days)
- Change in COPD Assesment Test (CAT)(29 days)
- Delta(TR-gradient)(4 days)
研究者
研究点 (5)
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