Barst 1996.
Methods | Randomised, parallel‐group, open‐label trial | |
Participants | Primary pulmonary hypertension who were NHYA III or IV despite optimal treatment (which included anticoagulants, oral vasodilators (68% in each group), diuretic agents, cardiac glycosides, and supplemental oxygen n = 81 |
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Interventions | Intravenous epoprostenol (flolan) versus conventional therapy mean max dose of epoprostenol was 9.2 + 0.5 ng/kg/min |
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Outcomes | 6MWD, cardiopulmonary haemodynamics, Chronic Heart Failure Questionnaire, Dyspnoea Fatigue Rating, clinical worsening (transplantation), adverse events, mortality Outcomes measured at 12 weeks |
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Notes | Partly industry funded and partly publicly funded ‐ "Supported in part by Burroughs Wellcome, Research Triangle Park, N.C. Dr.Rubin is the recipient of an academic award in vascular disease from the National Heart, Lung, and Blood Institute. Dr. Badesch is the recipient of a clinical investigator award from the National Institutes of Health". | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | A computer‐generated, adaptive randomisation was performed, with stratification according to the functional class, study centre, and baseline vasodilator use |
Allocation concealment (selection bias) | Unclear risk | Not clear |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Open‐label study |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Unclear |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Dropouts reported |
Selective reporting (reporting bias) | Low risk | All outcomes were reported |
Other bias | Low risk | Other bias unlikely |