UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054786 |
|---|---|
| Receipt number | R000062606 |
| Scientific Title | An observational study on the long-term utility and the safety of the transition from parenteral prostanoids to selexipag in pulmonary arterial hypertension |
| Date of disclosure of the study information | 2024/07/30 |
| Last modified on | 2025/05/27 16:54:07 |
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Basic information
Public title
An observational study on the long-term utility and the safety of the transition from parenteral prostanoids to selexipag in pulmonary arterial hypertension
Acronym
An observational study on the long-term utility and the safety of the transition from parenteral prostanoids to selexipag in pulmonary arterial hypertension
Scientific Title
An observational study on the long-term utility and the safety of the transition from parenteral prostanoids to selexipag in pulmonary arterial hypertension
Scientific Title:Acronym
An observational study on the long-term utility and the safety of the transition from parenteral prostanoids to selexipag in pulmonary arterial hypertension
Region
| Japan |
Condition
Condition
pulmonary arterial hypertension
Classification by specialty
| Cardiology | Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to assess the long-term utility and the safety of the transition from parenteral prostanoids to selexipag in patients with idiopathic/heritable pulmonary arterial hypertension (I/HPAH) whose clinical conditions have improved with combination therapy including parenteral prostanoids.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Parenteral free survival after the transition
Key secondary outcomes
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
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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
Key exclusion criteria
none
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Yuichi |
| Middle name | |
| Last name | Tamura |
Organization
International University of Health and Welfare, Mita Hospital
Division name
Cardiovascular Center
Zip code
108-8329
Address
1-4-3 Mita, Minato-ku Tokyo, 108-8329 JAPAN
TEL
0334518121
u1@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Yuichi |
| Middle name | |
| Last name | Tamura |
Organization
International University of Health and Welfare, Mita Hospital
Division name
Cardiovascular Center
Zip code
108-8329
Address
1-4-3 Mita, Minato-ku Tokyo, 108-8329 JAPAN
TEL
0334518121
Homepage URL
u1@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare, Mita Hospital
Institute
Department
Personal name
Funding Source
Organization
Nippon Shinyaku
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
International University of Health and Welfare, Mita Hospital,
Address
1-4-3 Mita, Minato-ku Tokyo, 108-8329 JAPAN
Tel
0334518121
rinri-mita@iuhw.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 07 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 06 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 27 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 27 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1. OS
2. Clinical worsening-free survival
3. Right Heart Catheterization
4. WHO FC
5. 6MWD
6. BNP
7. 4-strata
8. QOL
9. Side Effect
Management information
Registered date
| 2024 | Year | 06 | Month | 26 | Day |
Last modified on
| 2025 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062606
