Efficacy of Beraprost in Lowering Pulmonary Arterial Pressure in Children

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

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.

Study Overview

• Status: Completed
• Conditions: Pediatric Pulmonary Hypertension
• Intervention / Treatment: Drug: Beraprost Sodium; Drug: Sildenafil Citrate

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• Indonesia
  • East Java
    • Surabaya, East Java, Indonesia
      • Dr. Soetomo General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Dr. Soetomo General Hospital
• Investigators: Study Director: Mahrus Rachman, MD, Dr. Soetomo General Hospital

Publications and helpful links

General Publications

• 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. doi: 10.1007/s00246-005-0925-4.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Actual): July 30, 2017
• Study Completion (Actual): October 30, 2017

Study Registration Dates

• First Submitted: July 29, 2017
• First Submitted That Met QC Criteria: February 12, 2018
• First Posted (Actual): February 13, 2018

Study Record Updates

• Last Update Posted (Actual): February 13, 2018
• Last Update Submitted That Met QC Criteria: February 12, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Hypertension, Pulmonary; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Urological Agents; Enzyme Inhibitors; Platelet Aggregation Inhibitors; Phosphodiesterase Inhibitors; Phosphodiesterase 5 Inhibitors; Beraprost; Sildenafil Citrate
• Other Study ID Numbers: TAshirley

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No