Efficacy of Beraprost in Lowering Pulmonary Arterial Pressure in Pulmonary Arterial Hypertension Children Associated With Left to Right Shunt Congenital Heart Defect
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Efficacy of Beraprost, Sildenafil and comparison between both drugs in lowering pulmonary arterial pressure
研究概览
简要总结
To analyze the efficacy of beraprost and sildenafil for treatment of pulmonary hypertension in children with left to right shunt.
analyze the efficacy and side effects.
详细描述
Eligibility criteria:
Inclusion:
-
children aged 1-17 years with left to right shunt, diagnosed as pulmonary hypertension.
-
free from chronic pulmonary disease
-
never performed any cardiac surgical
-
never got any treatment for PH
-
agree to enroll in this study. Exclusion
-
suffer from portal hypertension, HIV and connective tissue disease 2. under interferon therapy.
Outcome measure:
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
- Double (Participant, Outcomes Assessor)
盲法说明
the researchers don't know which drug taken by the patient and don't know the previous PA pressure
入排标准
- 年龄范围
- 1 Year 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed as pulmonary hypertension with left to right shunt CHD (VSD, ASD, PDA and combination)
- •agree to enroll in this study
排除标准
- •suffer from chronic lung disease
- •suffer from soft tissue tumor, HIV/AIDS
- •under interferon therapy
- •already performed any cardiac surgery
- •already got anti-PH remedy
研究组 & 干预措施
Beraprost Sodium
Beraprost 1mcg/kg/day, divided in 3 doses orally patient was followed up for 12 weeks, then echocardiography evaluation was performed in patient completed the study.
22 patients
干预措施: Beraprost Sodium (Drug)
Sildenafil citrate
Sildenafil 0.4 mg/kg/time, 4 times daily per oral patient was followed up for 12 weeks, then echocardiography evaluation was performed in patient completed the study.
20 patients
干预措施: Sildenafil Citrate (Drug)
结局指标
主要结局
Efficacy of Beraprost, Sildenafil and comparison between both drugs in lowering pulmonary arterial pressure
时间窗: 12 weeks
Measuring mPAP (pre-post therapy) via echocardiography before and after consuming sildenafil or beraprost
次要结局
- Emergent Adverse Events(12 weeks)
研究者
Dr. dr. Mahrus A. Rahman Sp.A(K)
Doctor
Dr. Soetomo General Hospital