Selexipag Research for PAH

JRCT ID: jRCT1051220173

Registered date:22/02/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Pulmonary arterial hypertension
• Date of first enrollment: 31/01/2023
• Target sample size: 100
• Study type: Observational

Outcome(s)

• Primary Outcome: Change in PVR between baseline and 52 weeks after Selexipag administration

Secondary Outcome

1) Changes of catheter-related parameters (mean PAP, PAWP, PVR, CI, SaO2, SpO2, SvO2, PaO2, PaCO2, RAP, RVP, SaO2, SpO2, SvO2, PaO2, PaCO2) at 26 weeks and 104 weeks from baseline after initiation of Selexipag.

Below, change from baseline at 26 weeks, 52 weeks, and 104 weeks after initiation of selexipag
2) Exercise tolerance (6-minute walk distance (6MWD), minimum SpO2, Borg dyspnea index).
3) Cardiac function (cardiac MRI {right ventricular end diastolic volume index (RVEDVI), right ventricular end systolic volume index (RVESVI), right ventricular ejection fraction (RVEF), left ventricular end diastolic volume index (LVEDVI), left ventricular end systolic volume index (LVESVI), left ventricular ejection fraction (LVEF)))
4) Serum markers (brain natriuretic peptide (BNP), thyroid function (thyroid stimulating hormone (TSH), free T4)).
5) Changes in respiratory function (respiratory function tests {total lung capacity (TLC), forced lung capacity (FVC), fraction of one second (%FEV1.0), diffusing capacity of the lung for carbon monoxide (DLCO), FVC/DLCO ))
6) WHO FC
7) Risk classification (COMPERA risk assessment classification)
Patients are classified as low risk, intermediate risk, or high risk according to WHO FC, 6MWD, BNP, RAP, CI, and SvO2 cut off values.
8)
A) Time until the first occurrence of any of the following clinically worsening events during the observation period
-Death (any cause)
-Hospitalization due to worsening PAH
-Non-expected hospitalization for worsening PAH with signs and symptoms of right ventricular failure (over 24 hours)
-Lung transplantation or atrial septal dissection
-Parenteral prostanoid therapy or long-term oxygen therapy due to worsening PAH
-Disease progression with all of the following
- Shortening of 6MWD by at least 15% from baseline
- Worsening of WHO FC
B) Time to first occurrence of a fatal event during the observation period
C) Time to first occurrence of hospitalization due to worsening PAH during the observation period
9) Side effects during the observation period
-Type of side effect
-Number of adverse reactions

Translated with www.DeepL.com/Translator (free version)

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both
• Include criteria: PAH patients treated with selexipag between November 21, 2016, and July 31, 2022, at the Division of Pulmonary Circulation, National Cerebral and Cardiovascular Center (including PAH patients who were introduced to selexipag at other hospitals and referred to National Cerebral and Cardiovascular Center)
• Exclude criteria: Patients who have requested that their information not be used by the patient or his/her family

Related Information

• Primary Sponsor: Ogo Takeshi
• Secondary Sponsor: Asano Ryotaro