Trial | NCT03431649  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    40
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.
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

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

Outcome measure:

Pulmonary artery pressure
Study Started
Apr 01
2017
Primary Completion
Jul 30
2017
Study Completion
Oct 30
2017
Last Update
Feb 13
2018

Drug Sildenafil Citrate

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

  • Other names: Viagra

Drug Beraprost Sodium

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

  • Other names: Dorner

Beraprost Sodium Experimental

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 Active Comparator

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

Criteria 

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
No Results Posted