Observational study of PAH patients treated with PAH-specific therapy
Research type
Research Study
Full title
Post-authorisation safety study (PASS): observational cohort study of PAH patients newly treated with either Uptravi® (selexipag) or any other PAH-specific therapy, in clinical practice
IRAS ID
249695
Contact name
Martin Johnson
Contact email
Sponsor organisation
Actelion Pharmaceuticals Ltd.
Duration of Study in the UK
4 years, 6 months, 1 days
Research summary
Pulmonary arterial hypertension is high blood pressure in the blood vessels that supply the lungs (pulmonary arteries). It’s a serious condition that can damage the right side of the heart. The walls of the pulmonary arteries become thick and stiff, and can’t expand as well to allow blood through. The reduced blood flow makes it harder for the right-hand side of the heart to pump blood through the arteries.\nEXPOSURE is an information-collecting (observational) study, that means no extra examination or intervention will be required for the study; only information that is obtained as part of participants normal medical care will be collected. \nThe purpose of EXPOSURE is to collect information so that the use in the everyday medical practice and the safety of Uptravi® for Pulmonary Arterial Hypertension (PAH) and other PAH specific treatments can be understood better.\nThe care participants receive while taking part in EXPOSURE will be the same as the care they would normally receive when not taking part in this study. If participants agree to take part in EXPOSURE, information about their disease and the treatment of their disease will be electronically collected for at least 18 months, starting from the date that participants agree to take part. After signing the Informed Consent Form, a medical history will be obtained by talking to the participant and by reviewing their past medical records. Thereafter, medical information will be collected when participants see their doctor at routine visits, or if they are in hospital.\nIn the secured database where the information of all patients are kept and analysed, information that could identify participants personally (e.g. date of birth and initials) are removed and replaced by a number.\n
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
19/YH/0062
Date of REC Opinion
8 Apr 2019
REC opinion
Further Information Favourable Opinion