Trial · NCT07356375
Patient-Reported Outcomes and Adherence After Transition From Inhaled Iloprost to Oral Selexipag in Pulmonary Arterial Hypertension
NCT07356375, Not yet recruiting, University of Sao Paulo General Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Patient-Reported Outcomes and Adherence After Transition From Inhaled Iloprost to Oral Selexipag in Pulmonary Arterial Hypertension. Trials, record NCT07356375. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07356375
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Patient-Reported Outcomes and Adherence After Transition From Inhaled Iloprost to Oral Selexipag in Pulmonary Arterial Hypertension
- NCT number
- NCT07356375
- Status
- Not yet recruiting
- Enrollment
- 32 participants, estimated
- Lead sponsor
- University of Sao Paulo General Hospital
- Conditions
- Pulmonary Arterial Hypertension (PAH)
- Interventions
- Selexipag
- First posted
- 2026-01-21
- Last updated
- 2026-02-13
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Health-Related Quality of Life (EMPHASIS-10) | From baseline (prior to transition) to 16-24 weeks of follow-up | 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. |
| Secondary | Change in Treatment Satisfaction (TSQM-9) | From baseline (prior to transition) to 3-4 weeks and 16-24 weeks after transition | 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. |
| Secondary | Patient Global Impression of Change (PGIC) | 3-4 weeks and 16-24 weeks after transition | 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. |
| Secondary | Objective Adherence to Selexipag | From transition to 16-24 weeks of follow-up | 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. |
| Secondary | Perceived Treatment Burden | From baseline (prior to transition) to 16-24 weeks after transition | 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. |
| Secondary | Adverse Events and Health Care Utilization | From transition to 16-24 weeks of follow-up | Occurrence of adverse events and health care utilization, including hospitalizations and unplanned outpatient visits, recorded during routine clinical follow-up after transition to oral selexipag. |
| Secondary | Responder Status Based on EMPHASIS-10 | From baseline to 16-24 weeks of follow-up | Proportion of patients achieving a clinically meaningful improvement in health-related quality of life, defined as a decrease of at least 6 points (minimal clinically important difference) in the EMPHASIS-10 score between baseline and follow-up. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07356375
GET https://conductscience.org/api/trials/v1/NCT07356375/registered