Efficacy of Beraprost in Lowering Pulmonary Arterial Pressure in Children

Study Overview
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Brief Summary
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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.

Detailed Description
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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 1. suffer from portal hypertension, HIV and connective tissue disease 2. under interferon therapy. Outcome measure: Pulmonary artery pressure

Official Title
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Efficacy of Beraprost in Lowering Pulmonary Arterial Pressure in Pulmonary Arterial Hypertension Children Associated With Left to Right Shunt Congenital Heart Defect

Conditions
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Pediatric Pulmonary Hypertension

Intervention / Treatment
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* Drug: Beraprost Sodium
* Drug: Sildenafil Citrate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosed as pulmonary hypertension with left to right shunt CHD (VSD, ASD, PDA and combination) agree to enroll in this study Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Beraprost Sodium<br>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 | Drug: Beraprost Sodium<br>* 1 mcg /kgbw daily, divided in three dosages orally for 12 weeks<br>* Other names: Dorner;|
| Active Comparator: Sildenafil citrate<br>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 | Drug: Sildenafil Citrate<br>* 0.4 mg/kgbw each time, 4 times in a day orally for 12 weeks<br>* Other names: Viagra;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of Beraprost, Sildenafil and comparison between both drugs in lowering pulmonary arterial pressure | Measuring mPAP (pre-post therapy) via echocardiography before and after consuming sildenafil or beraprost | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emergent Adverse Events | adverse event reported by patients and during weekly examination after consuming Beraprost or Sildenafil: hypotension, dizzy, headache, flushing, bleeding | 12 weeks |