Pulmonary Arterial Hypertension. Other secondary pulmonary hypertension
Conditions
Interventions
Intervention 1: Case group:
Prescription of Farantan (Bosentan) tablet 125 mg, orally, twice a day, for 2 years. Intervention 2: Control group: prescription of placebo, completely similar to Farantan
Treatment - Drugs
Case group:
Prescription of Farantan (Bosentan) tablet 125 mg, orally, twice a day, for 2 years
Control group: prescription of placebo, completely similar to Farantan tablet, orally, 125 mg twice a day for 2 years
Sponsors
Faran Pharmaceutical Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion: • The cases of pulmonary arterial hypertension (PAH), secondary to cardiac or connective tissue disorders (e.g. scleroderma, Eisenmenger's syndrome, etc.), which are in functional class II or higher (Due to drug deficiency and national guideline, Traclleer has not been prescribed for these patients, so far); • No finding of anemia, liver disorders, pregnancy and lactation, body fluid retention, peripheral or pulmonary edema and respiratory system infections; • No prescription of interactive medicines like Cyclosporine A and Glyburide; • Having voluntarily willingness for participation in the study; Exclusion: • Drug intolerance due to any reason; • Any severe or relatively severe side effects like increasing liver function tests (more than 3 times of baseline or 2 times of normal), anemia, severe pulmonary infection, fluid retention and edema, etc.; • Discontinuing of participation by the participants; • Irregular intake of Farantan due to any reason; • Any undesirable medical condition which urge the physicians to change the treatment.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6 Minutes Walking Test (6MWT). Timepoint: monthly up to 6 month & then every 3 months. Method of measurement: Distanse of walking in 6 minutes (in standard conditions). | — |
Secondary
| Measure | Time frame |
|---|---|
| ProBNP. Timepoint: at the begining and then every 3 months. Method of measurement: Enzyme-Linked Fluorescent Assay.;CBC. Timepoint: monthly up to 6 month & then every 3 months. Method of measurement: Autoanalyzer equipments.;Liver function test. Timepoint: monthly up to 6 month & then every 3 months. Method of measurement: Autoanalyzer equipments. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Kayvan Saeedfar
National Research Institute of Tuberculosis and Lung Diseases
Outcome results
None listed