Efficacy of Beraprost in Lowering Pulmonary Arterial Pressure in Children

Dr. Soetomo General Hospital

Status and phase: Completed; Phase 4

Conditions: Pediatric Pulmonary Hypertension

Treatments: Drug: Sildenafil Citrate; Drug: Beraprost Sodium

Study type: Interventional

Funder types: Other

Identifiers

NCT03431649

TAshirley

Details and patient eligibility

About

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.

Full description

Eligibility criteria:

Inclusion:

1. children aged 1-17 years with left to right shunt, diagnosed as pulmonary hypertension.

2. free from chronic pulmonary disease

3. never performed any cardiac surgical

4. never got any treatment for PH

5. agree to enroll in this study. Exclusion

6. suffer from portal hypertension, HIV and connective tissue disease 2. under interferon therapy.

Outcome measure:

Pulmonary artery pressure

Enrollment: 40 patients

Sex: All

Ages: 1 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Beraprost Sodium

Experimental group

Description:

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

Treatment:

Drug: Beraprost Sodium

Sildenafil citrate

Active Comparator group

Description:

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

Treatment:

Drug: Sildenafil Citrate