An observational study on the long-term utility and the safety of the transition from parenteral prostanoids to selexipag in pulmonary arterial hypertension

An observational study on the long-term utility and the safety of the transition from parenteral prostanoids to selexipag in pulmonary arterial hypertension - An observational study on the long-term utility and the safety of the transition from parenteral prostanoids to selexipag in pulmonary arterial hypertension

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000054786

Enrollment

Registered

2024-07-30

Start date

2024-08-27

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pulmonary arterial hypertension

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who meet all of the following inclusion criteria 1.Patients with I/HPAH who have attended or been admitted to the Department of Cardiology, Cardiovascular Center, International University of Health and Welfare, Mita Hospital 2.Patients whose clinical conditions have improved significantly with triple combination therapy including parenteral prostanoids and transitioned to selexipag according to the structured transition protocol 3.Patients who completed 12-month follow-up after the transition by the cutoff date 4.Patients aged 18 years or older at the time of inclusion

Exclusion criteria

Exclusion criteria: none

Design outcomes

Primary

Measure	Time frame
Parenteral free survival after the transition	—

Secondary

Measure	Time frame
1.Overall survival after the transition 2.Clinical worsening-free survival to first occurrence of any of the following events after the transition - Death (all causes) - Hospitalization for worsening of PAH Following values at each observation point 3.Hemodynamic parameters: pulmonary vascular resistance, mean pulmonary arterial pressure, pulmonary arterial wedge pressure, cardiac index, arterial oxygen saturation, percutaneous oxygen saturation, mixed venous oxygen saturation, partial pressure of arterial oxygen, partial pressure of arterial carbon dioxide, right atrial pressure, right ventricular pressure 4.WHO functional class 5.Six-minute walk distance 6.Brain natriuretic peptide 7.Risk assessment (COMPERA 2.0: 4-stratum model) 8.QOL index: SF-36, emPHasis-10 9.Adverse drug reactions	—

Measure

Time frame

1.Overall survival after the transition 2.Clinical worsening-free survival to first occurrence of any of the following events after the transition - Death (all causes) - Hospitalization for worsening of PAH Following values at each observation point 3.Hemodynamic parameters: pulmonary vascular resistance, mean pulmonary arterial pressure, pulmonary arterial wedge pressure, cardiac index, arterial oxygen saturation, percutaneous oxygen saturation, mixed venous oxygen saturation, partial pressure of arterial oxygen, partial pressure of arterial carbon dioxide, right atrial pressure, right ventricular pressure 4.WHO functional class 5.Six-minute walk distance 6.Brain natriuretic peptide 7.Risk assessment (COMPERA 2.0: 4-stratum model) 8.QOL index: SF-36, emPHasis-10 9.Adverse drug reactions

—

Countries

Japan

Contacts

Public ContactYuichi Tamura

International University of Health and Welfare, Mita Hospital Cardiovascular Center

u1@iuhw.ac.jp0334518121

Outcome results