PAH medication
DrugThere will be no specific interventions.
NCT Number: NCT04567602
The purpose of the study is to evaluate the change from baseline to 12 months after study enrollment in the number of the following non-invasive risk criteria: World Health Organization Functional Class (WHO/FC), 6-minute walk distance (6MWD), Brain Natriuretic Peptide (BNP) or N-terminal pro-brain Natriuretic Peptide (NT-proBNP).
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Notify Me18 year and older
All sexes
Observational
Generale Regionale F. Miulli, Acquaviva delle Fonti, Italy
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
There will be no specific interventions.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline up to 24 Months
Change from baseline in 6MWD will be reported.
Time frame: Baseline up to 24 Months
Change from baseline in BNP or NT-proBNP will be reported.
Time frame: 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.
Time frame: Up to 24 Months
Adherence to ESC/ERS guidelines and 6th WSPH will be reported.
Time frame: Baseline up to 24 Months
Change in echocardiographic parameters will be reported as assessed by echocardiogram.
Time frame: Baseline up to 24 Months
Change in hemodynamic parameters will be reported.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Janssen-Cilag S.p.A.
Industry
Non-Interventional Study on Pulmonary Arterial Hypertension Patients Treated With Macitentan or Selexipag: Experience From an Italian Cohort (INSPECTIO)
Acronym: INSPECTIO
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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