Patient-Reported Outcomes and Adherence After Transition From Inhaled Iloprost to Oral Selexipag in Pulmonary Arterial Hypertension

NCT07356375 | Not Yet Recruiting

• 1 other identifier: SGP 27905
• Study Type: observational
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Pulmonary Arterial Hypertension (PAH)

Keywords

Pulmonary Arterial Hypertension; Prostacyclin Pathway; Patient-Reported Outcomes; Quality of Life; Treatment Adherence; Real-World Evidence; Iloprost; Selexipag; Observational Study

Outcome Measures

Primary Outcomes (1)

• 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.

  From baseline (prior to transition) to 16-24 weeks of follow-up

Secondary Outcomes (6)

• Change in Treatment Satisfaction (TSQM-9)

  From baseline (prior to transition) to 3-4 weeks and 16-24 weeks after transition

• Patient Global Impression of Change (PGIC)

  3-4 weeks and 16-24 weeks after transition

• Objective Adherence to Selexipag

  From transition to 16-24 weeks of follow-up

• Perceived Treatment Burden

  From baseline (prior to transition) to 16-24 weeks after transition

• Adverse Events and Health Care Utilization

  From transition to 16-24 weeks of follow-up

Study Arms (1)

Iloprost to Selexipag Transition

Adult patients with pulmonary arterial hypertension receiving inhaled iloprost whose treating physician decides, as part of routine clinical care, to transition treatment to oral selexipag. Patients are followed prospectively to assess changes in patient-reported outcomes, treatment satisfaction, and adherence before and after the transition. All treatment decisions are made by the treating physician, and no study-related intervention is performed.

Drug: Selexipag

Interventions

Selexipag DRUG

Exposure 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.

Also known as: Oral selexipag, IP receptor agonist

Iloprost to Selexipag Transition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.
• Ability to understand and complete patient-reported outcome questionnaires.
• Provision of written informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Related Publications (1)

• 1. Simonneau G, Montani D, Celermajer DS, Denton CP, Gatzoulis MA, Krowka M, et al. Haemodynamic definitions and updated clinical classification of pulmonary hypertension. Eur Respir J. janeiro de 2019;53(1):1801913. 2. Humbert M, Sitbon O, Simonneau G. Treatment of Pulmonary Arterial Hypertension. N Engl J Med. 30 de setembro de 2004;351(14):1425-36. 3. Calderaro D, Alves Junior JL, Fernandes CJCDS, Souza R. Pulmonary Hypertension in General Cardiology Practice. Arq Bras Cardiol [Internet]. 2019 [citado 24 de agosto de 2024]; Disponível em: https://www.scielo.br/scielo.php?pid=S0066-782X2019000900419&script=sci_arttext 4. Yoo HHB. Lesões Plexiformes na Hipertensão Arterial Pulmonar: Estamos Ficando mais Próximos do Manejo com mais Paciência e Rigor? Arq Bras Cardiol. 18 de setembro de 2020;115(3):491-2. 5. D'Alonzo GE, Barst RJ, Ayres SM, Bergofsky EH, Brundage BH, Detre KM, et al. Survival in patients with primary pulmonary hypertension. Results from a national prospective registry. Ann Intern Med. 1o de setembro de 1991;115(5):343-9. 6. Barst RJ, Rubin LJ, Long WA, McGoon MD, Rich S, Badesch DB, et al. A comparison of continuous intravenous epoprostenol (prostacyclin) with conventional therapy for primary pulmonary hypertension. N Engl J Med. 1o de fevereiro de 1996;334(5):296-301. 7. Galiè N, Ghofrani HA, Torbicki A, Barst RJ, Rubin LJ, Badesch D, et al. Sildenafil citrate therapy for pulmonary arterial hypertension. N Engl J Med. 17 de novembro de 2005;353(20):2148-57. 8. Rubin LJ, Badesch DB, Barst RJ, Galiè N, Black CM, Keogh A, et al. Bosentan Therapy for Pulmonary Arterial Hypertension. N Engl J Med. 21 de março de 2002;346(12):896-903. 9. Hoeper MM, Badesch DB, Ghofrani HA, Gibbs JSR, Gomberg-Maitland M, McLaughlin VV, et al. Phase 3 Trial of Sotatercept for Treatment of Pulmonary Arterial Hypertension. N Engl J Med. 20 de abril de 2023;388(16):1478-90. 10. Mitchell JA, Ahmetaj-Shala B, Kirkby NS, Wright WR, Mackenzie LS, Reed DM, et al. Role of pr

  BACKGROUND

MeSH Terms

Conditions

Pulmonary Arterial Hypertension; Treatment Adherence and Compliance

Interventions

selexipag

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases; Health Behavior; Behavior

Study Officials

• Caio Fernandes, MD

  UNIVERSIDADE SAO PAULO

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caio Fernandes Principal Investigator, MD

CONTACT

+551126615034; cjcfernandes@yahoo.com.br

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pulmonologist, PhD

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: January 21, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share