Efficacy of Beraprost in Lowering Pulmonary Arterial Pressure in Children

Pediatric Pulmonary Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03431649
• Other study ID #: TAshirley
• Status: Completed
• Phase: Phase 4
• First received: July 29, 2017
• Last updated: February 12, 2018
• Start date: April 1, 2017
• Est. completion date: October 30, 2017

Study information

• Verified date: February 2018
• Source: Dr. Soetomo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 30, 2017
• Est. primary completion date: July 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pediatric Pulmonary Hypertension

Intervention

Drug:
• Beraprost Sodium
1 mcg /kgbw daily, divided in three dosages orally for 12 weeks
• Sildenafil Citrate
0.4 mg/kgbw each time, 4 times in a day orally for 12 weeks

Locations

Country	Name	City	State
Indonesia	Dr. Soetomo General Hospital	Surabaya	East Java

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Soetomo General Hospital

Country where clinical trial is conducted

Indonesia, 

References & Publications (1)

Limsuwan A, Pienvichit P, Khowsathit P. Beraprost therapy in children with pulmonary hypertension secondary to congenital heart disease. Pediatr Cardiol. 2005 Nov-Dec;26(6):787-91. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Emergent Adverse Events	adverse event reported by patients and during weekly examination after consuming Beraprost or Sildenafil: hypotension, dizzy, headache, flushing, bleeding	12 weeks