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NCT07356375Not yet recruiting

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

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

Source: ClinicalTrials.gov · Last updated 13 Feb 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
32 (estimated)
First submitted
12 Jan 2026
Start date
1 Mar 2026
Primary completion date
31 Dec 2026
Lead sponsor
University of Sao Paulo General Hospital
NCT number
NCT07356375

What you commit to

  • Study type: Observational
  • Planned participants: 32
  • From 1 Mar 2026 to the primary completion date, 31 Dec 2026
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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.

Other

  • Refusal or inability to provide informed consent.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.