Efficacy of Beraprost in Lowering Pulmonary Arterial Pressure in Children

Phase 4

Completed

• Conditions: Pediatric Pulmonary Hypertension
• Interventions: Drug: Beraprost Sodium; Drug: Sildenafil Citrate

• Registration Number: NCT03431649
• Lead Sponsor: Dr. Soetomo General Hospital

Brief Summary

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

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

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

Outcome measure:

Pulmonary artery pressure

Study Timeline

• Study Start: 2017-04-01
• Study First Submitted: 2017-07-29
• Primary Completion: 2017-07-30
• Study Completion: 2017-10-30
• Status Verified: 2018-02
• Study First Submitted QC: 2018-02-12
• Last Update Submitted: 2018-02-12
• Study First Posted: 2018-02-13
• Last Update Posted: 2018-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Beraprost Sodium	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
Sildenafil citrate	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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Emergent Adverse Events	12 weeks	adverse event reported by patients and during weekly examination after consuming Beraprost or Sildenafil: hypotension, dizzy, headache, flushing, bleeding

Trial Locations

Locations (1)

Dr. Soetomo General Hospital; 🇮🇩 Surabaya, East Java, Indonesia