Registered outcomes15

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 15 of 15

List	Outcome	Time frame	Description
Primary	Change from Baseline in the Number of the Non-Invasive Low-Risk Criteria to 12 Months	Baseline and 12 Months	Change from baseline in the number of the non-invasive low-risk criteria will be assessed according to the following parameters: world health organization (WHO)/functional class (FC)- I, II, 6-minute walk distance (6MWD) greater than (\>) 440 meters (m), and brain natriuretic peptide (BNP) less than (\<) 50 nanogram per liter (ng/l) or N-terminal-pro-hormone brain natriuretic Peptide (NT-proBNP) \<300 ng/l.
Secondary	Number of Participants with Improved, Stable or Worsened Risk profile from Baseline to 12 and 24 Months	Baseline up to 12 and 24 Months	Risk profile is assessed as improved, stable or worsened where improved indicates 1 or more non-invasive parameters from intermediate to low risk profile; stable indicates no change in the parameters; and worsened indicates 1 or more non-invasive parameters move from low or intermediate to intermediate or high range risk.
Secondary	Change in Progression in the Number of Participants with Low/High Intermediate Risk	Baseline up to 24 Months	Change in risk profile for the low/high intermediate risk participants according to following cut-off values for low intermediate risk/high intermediate risk, respectively: (6MWD \[greater than or equal to \[\>=\] or \< 300m\], Peak oxygen consumption \[VO2\] \[\>= or \< 50% predicted\], BNP \[less than or equal to \[\<=\] or \> 175 ng/l\], or NT-proBNP \[\<= or \> 850 ng/l\], right atrial area \[RA\] \[\<= or \> 22 centimeter \[cm\]\] and right atrial pressure \[RAP\] \[\<= or \> 11 millimeter of mercury \[mmHg\]\] or stroke volume index (SVI) (\> or \<= 38 milliliter per meter square \[ml/m2\])). The low intermediate risk is defined by a presence of at least three low intermediate parameters and a high intermediate risk is defined by a presence of at least three high intermediate parameters.
Secondary	Change from Baseline in 6MWD	Baseline up to 24 Months	Change from baseline in 6MWD will be reported.
Secondary	Change from Baseline in BNP or NT-proBNP	Baseline up to 24 Months	Change from baseline in BNP or NT-proBNP will be reported.
Secondary	Change from Baseline in Registry to Evaluate Early and Long-term PAH Disease Management (REVEAL) 2.0 Risk Score up to 12 and 24 Months	Baseline up to 12 and 24 Months	The REVEAL risk calculator determines the risk status and the scores can be defined as: low risk as a score of \<= 6, intermediate risk as a score of 7 or 8, and high risk as a score of \>= 9 for the survival rates.
Secondary	Adherence to European Society of Cardiology and European Respiratory Society (ESC/ERS) guidelines and 6th World Symposium on Pulmonary Hypertension (WSPH)	Up to 24 Months	Adherence to ESC/ERS guidelines and 6th WSPH will be reported.
Secondary	Change from Baseline in Echocardiographic Parameters	Baseline up to 24 Months	Change in echocardiographic parameters will be reported as assessed by echocardiogram.
Secondary	Change from Baseline in Hemodynamic Parameters	Baseline up to 24 Months	Change in hemodynamic parameters will be reported.
Secondary	Hospitalization Rate due to Worsening of PAH	Up to 24 Months	The hospitalization rate due to PAH worsening will be calculated based on the number of participants with at least one hospitalization. The calculation of the rate will be based on the number of events over the whole follow-up time that is exposure time.
Secondary	Overall Survival (OS)	Up to 24 Months	OS is defined as the duration/time from the start of study treatment to date of death due to any cause.
Secondary	Change from Baseline in Health-Related Quality of Life (HRQoL) as Measured with Emphasis-10 Questionnaire	Baseline up to 24 Months	The emPHasis-10 is a short and easy questionnaire that consists of 10 items which address breathlessness, fatigue, control and confidence. Each item is scored on a semantic differential six-point scale (0-5), with contrasting adjectives at each end. A total emPHasis-10 score is derived using simple aggregation of the 10 items. emPHasis-10 scores range from 0 to 50, higher scores indicate worse quality of life.
Secondary	Change from Baseline in Participants with Narrative plots	Baseline and 12 Months	Participants will be invited to fill in two narrative plots; one at the enrollment visit and one at the month 12 visit.
Secondary	Change from Baseline in Caregivers with Narrative Plots	Baseline and 12 Months	Caregivers will be invited to fill in two narrative plots; one at the enrollment visit and one at the month 12 visit.
Secondary	Number of Participants with Adverse Events (AEs) and Adverse Drug Reactions (ADRs)	Up to 24 Months	An AE is any untoward medical occurrence in a participant enrolled in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. An ADR is defined as a response to a medicinal (investigational or non-investigational) product that is noxious and unintended.

Source ClinicalTrials.govtrials-2026-11-12-0.4.0

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.

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