Pulmonary arterial hypertension (PAH) is a rare and serious condition that affects the blood vessels of the lungs and can significantly limit daily activities and quality of life. Some patients with PAH use inhaled iloprost, a medication that requires several inhalations per day, which can be difficult to maintain over time. Oral selexipag is an alternative treatment that may reduce treatment burden and improve adherence.
The PROMISE study aims to evaluate how switching from inhaled iloprost to oral selexipag affects patients' quality of life, satisfaction with treatment, and adherence in real-world clinical practice. Patient-reported outcome questionnaires will be used to understand patients' perceptions of symptoms, daily functioning, and overall improvement after the transition.
Adult patients with PAH who are receiving inhaled iloprost and whose physicians decide to switch treatment to oral selexipag will be followed over time. A comparison group of patients who continue using inhaled iloprost will also be observed. The study does not involve any experimental treatment or changes to routine clinical care. All medications are prescribed as part of standard medical practice.
The results of this study may help improve understanding of the patient experience during treatment transitions in PAH and support more patient-centered treatment decisions.
Adults aged 18 years or older.
Confirmed diagnosis of pulmonary arterial hypertension (PAH, Group 1) by right heart catheterization.
Current treatment with inhaled iloprost as part of routine clinical care.
Clinical decision by the treating physician to transition from inhaled iloprost to oral selexipag.
Significant cognitive impairment or sensory deficits that prevent completion of study questionnaires.
Unstable or decompensated comorbid conditions that may interfere with treatment adherence or study participation.
Refusal or inability to provide informed consent.
The study population consists of adult patients with a confirmed diagnosis of pulmonary arterial hypertension (PAH, Group 1) who are receiving inhaled iloprost as part of routine clinical care at a specialized referral center. Eligible patients are those for whom the treating physician has decided, based on clinical judgment, to transition therapy from inhaled iloprost to oral selexipag. Participants are followed prospectively to assess patient-reported outcomes, treatment satisfaction, adherence, and safety associated with this treatment transition. All clinical decisions are made independently of study participation, and no study-mandated interventions are performed.
Cohort
Prospective
Selexipag
DrugExposure to oral selexipag following transition from inhaled iloprost as part of routine clinical care in adults with pulmonary arterial hypertension. The decision to initiate, titrate, or discontinue selexipag is made exclusively by the treating physician, independent of study participation. No study-mandated intervention or treatment assignment is performed. The study observes patient-reported outcomes, treatment satisfaction, and adherence associated with this treatment transition.
Change in Health-Related Quality of Life (EMPHASIS-10)
Change in health-related quality of life assessed by the emPHasis-10 questionnaire (Pulmonary Hypertension-Specific Quality of Life Instrument), measured as the difference in total score between baseline (prior to transition from inhaled iloprost to oral selexipag) and follow-up. The emPHasis-10 is a patient-reported outcome measure ranging from 0 to 50, with lower scores indicating better health-related quality of life. The outcome evaluates within-patient change following treatment transition in routine clinical practice.
Change in Treatment Satisfaction (TSQM-9)
Change in treatment satisfaction assessed using the Treatment Satisfaction Questionnaire for Medication (TSQM-9), measured before the transition from inhaled iloprost and after transition to oral selexipag. The TSQM-9 is a patient-reported outcome measure evaluating treatment effectiveness, convenience, and global satisfaction domains. Domain scores range from 0 to 100, with higher scores indicating greater treatment satisfaction. The outcome allows within-patient comparison of treatment satisfaction before and after the treatment switch in routine clinical practice.
Patient Global Impression of Change (PGIC)
Patient-reported global impression of change assessed using the Patient Global Impression of Change (PGIC) scale, reflecting the patient's overall perception of improvement or worsening following the transition from inhaled iloprost to oral selexipag. The PGIC is a patient-reported outcome measure consisting of a 7-point Likert scale ranging from "very much worse" to "very much improved," with higher scores indicating greater perceived improvement. This outcome also explores the correlation between PGIC ratings and changes in other patient-reported outcomes.
Objective Adherence to Selexipag
Objective treatment adherence assessed by the percentage of days with twice-daily selexipag use, treatment interruptions, and the highest titrated dose achieved during follow-up, as documented in routine clinical practice.
Perceived Treatment Burden
Perceived treatment burden evaluated before the transition, based on the number of daily inhalations with iloprost, and after the transition, based on patient-reported convenience of the oral selexipag regimen.
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