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Completed

NCT Number: NCT03431649

Efficacy of Beraprost in Lowering Pulmonary Arterial Pressure in Children

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.

Completed

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Key information

Conditions

Pediatric Pulmonary Hypertension

Age range

1 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dr. Soetomo General Hospital

Surabaya, East Java, Indonesia

About this study

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

Outcome measure:

Pulmonary artery pressure

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Beraprost Sodium

Drug

1 mcg /kgbw daily, divided in three dosages orally for 12 weeks

Other names: Dorner

sildenafil citrate

Drug

0.4 mg/kgbw each time, 4 times in a day orally for 12 weeks

Other names: Viagra

Primary outcomes

  1. Efficacy of Beraprost, Sildenafil and comparison between both drugs in lowering pulmonary arterial pressure

    Time frame: 12 weeks

    Measuring mPAP (pre-post therapy) via echocardiography before and after consuming sildenafil or beraprost

Secondary outcomes

  1. Emergent Adverse Events

    Time frame: 12 weeks

    adverse event reported by patients and during weekly examination after consuming Beraprost or Sildenafil: hypotension, dizzy, headache, flushing, bleeding

Sponsors and collaborators

Lead sponsor

Dr. Soetomo General Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Feb 13, 2018
Registry last updated
Feb 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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