This study is investigating the effect of switching from Flolan® to Epoprostenol for Injection (EFI/ACT-385781A) in pulmonary arterial hypertension patients currently treated with Flolan®. For this purpose patients being treated for at least 12 months with Flolan® will be switched from Flolan® to EFI/ACT-385781A and followed-up for 90 days. During these 90 days safety and tolerability of EFI/ACT-385781A will closely be monitored in all treated patients. This 90 follow-up will provide clinical evidence on the safety, tolerability, efficacy and treatment satisfaction of switching from Flolan® to EFI/ACT-385781A in patients with pulmonary arterial hypertension.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
UZ Gasthuisberg
Leuven, Belgium
University Health Network, Toronto TGH - 10 EN - 220
Toronto, Ontario, Canada
Sir Mortimer B Davis Jewish General Hospital
Montreal, Quebec, Canada
Centre Hospitalier Universitaire
Caen, France
Hôpital Antoine Béclère
Clamart, France
Orsola Malpighi
Bologna, Italy
VU Medisch Centrum (VUMC)
Amsterdam, Netherlands
Hospital Vall d'Hebron
Barcelona, Spain
Change in Pulmonary Vascular Resistance From Baseline to End of Treatment (EOT).
Right heart catheterization was performed for cardiac hemodynamic assessment at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT.
Time frame: Approximately 3 months
Change in Total Pulmonary Resistance From Baseline to End of Treatment (EOT).
Right heart catheterization was performed for cardiac hemodynamic assessment at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT.
Time frame: Approximately 3 months
Change in Mean Pulmonary Arterial Pressure From Baseline to End of Treatment (EOT).
Right heart catheterization was performed for cardiac hemodynamic assessment at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT.
Time frame: Approximately 3 months
Change in Mean Right Atrial Pressure From Baseline to End of Treatment (EOT).
Right heart catheterization was performed for cardiac hemodynamic assessment at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT.
Time frame: Approximately 3 months
Change in Pulmonary Capillary Wedge Pressure From Baseline to End of Treatment (EOT).
Right heart catheterization was performed for cardiac hemodynamic assessment at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT.
Time frame: Approximately 3 months
Change in Mean Cardiac Index From Baseline to End of Treatment (EOT).
Right heart catheterization was performed for cardiac hemodynamic assessment at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT.
Time frame: Approximately 3 months
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