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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:
1. suffer from portal hypertension, HIV and connective tissue disease 2. under interferon therapy.
Outcome measure:
Pulmonary artery pressure
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Beraprost Sodium | Drug | 1 mcg /kgbw daily, divided in three dosages orally for 12 weeks |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mahrus Rachman, MD | Dr. Soetomo General Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Soetomo General Hospital | Surabaya | East Java | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16132278 | Background | 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. |
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| ID | Term |
|---|---|
| C048081 | beraprost |
| D000068677 | Sildenafil Citrate |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 |
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the researchers don't know which drug taken by the patient and don't know the previous PA pressure
| Sildenafil Citrate | Drug | 0.4 mg/kgbw each time, 4 times in a day orally for 12 weeks |
|
|
| Sulfur Compounds |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |