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Efficacy of Beraprost in Lowering Pulmonary Arterial Pressure in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03431649
Recruitment Status : Completed
First Posted : February 13, 2018
Last Update Posted : February 13, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. dr. Mahrus A. Rahman Sp.A(K), Dr. Soetomo General Hospital

Study Description
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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.


Condition or disease Intervention/treatment Phase
Pediatric Pulmonary Hypertension Drug: Beraprost Sodium Drug: Sildenafil Citrate Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: the researchers don't know which drug taken by the patient and don't know the previous PA pressure
Primary Purpose: Treatment
Official Title: Efficacy of Beraprost in Lowering Pulmonary Arterial Pressure in Pulmonary Arterial Hypertension Children Associated With Left to Right Shunt Congenital Heart Defect
Actual Study Start Date : April 1, 2017
Actual Primary Completion Date : July 30, 2017
Actual Study Completion Date : October 30, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: Viagra


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   1 Year to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03431649


Locations
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Indonesia
Dr. Soetomo General Hospital
Surabaya, East Java, Indonesia
Sponsors and Collaborators
Dr. Soetomo General Hospital
Investigators
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Study Director: Mahrus Rachman, MD Dr. Soetomo General Hospital
More Information
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Publications:

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Responsible Party: Dr. dr. Mahrus A. Rahman Sp.A(K), Doctor, Dr. Soetomo General Hospital
ClinicalTrials.gov Identifier: NCT03431649    
Other Study ID Numbers: TAshirley
First Posted: February 13, 2018    Key Record Dates
Last Update Posted: February 13, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Sildenafil Citrate
Beraprost
 Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Urological Agents
Platelet Aggregation Inhibitors