Pulmonary arterial hypertension
Conditions
Interventions
Group B :beraprost combined with sildenafil
A:Sildenafil citrate
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Subject Inclusion Criteria: A subject is eligible for incl usion in this study if all of the following criteria apply: (1)The subject is between the ages of 18 and 65 years of age at Screening. (2)The subject has a diagnosis of Idiopathic PAH, PAH asso ciated with repaired congenital systemic-to-pulmonary shunts (repaired = 3 years), PAH associated with Collagen Vascular Disease. (3)Have regularly used sildenafil in the treatment of pulmonary hypertension 3 to 6 months. (4)The subject must have a Baseline 6-Minute Walk distance of between 150 and 450 meters. (5)The subject must have a Baseline WHO function Classification of II to IV . (6)The subject has previously undergone a cardiac catheterization and have negative acute pulmonary vasodilator testing. (7)The subject will voluntarily give informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: Subject Exclusion Criteria A subject is not eligible for inclusion in this study if any of the following criteria apply: (1)The subject has any disease associated with pul monary arterial hypertension other than IPAH,collagen vascular disease, HIV, or repaired congenital systemic-to-pulmonary shunts (repaired =3years). (2)The subject refused to sign the informed consent, or not in the course of the experiment with the researchers. (3)The subject has severe acute or chronic hepatic, renal and central nervous system diseases (4) The subject has unstable angina, or experienced a myocardial infarction, stroke or life-threatening arrhythmia within 6 months before enrolling the trial. (5)The subject has received or are receiving vardenafil, bosentan or iloprost for pulmonary arterial hypertension within 6 months. (6)The subject has contraindications with beraprost and sildenafil.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| six minutes walk distance;Mixed venous oxygen saturation Type: Secondary indicator; | — |
Secondary
| Measure | Time frame |
|---|---|
| WHO Function Class;Uric acid;NT-proBNP;mean pulmonary arterial pressure;Pulmonary vascular resistance;Cardiac index;Three tricuspid systolic displacement;Pericardial effusion Type: Secondary indicator;Left ventricular end diastolic eccentricity index;Right atrial area;The proportion of clinical worsening events and time to clinical worsening events; | — |
Countries
China
Contacts
Public ContactZhi-Cheng JING
Outcome results
None listed