UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056006 |
|---|---|
| Receipt number | R000064005 |
| Scientific Title | A non-interventional observational study evaluating the efficacy and safety of selexipag in pulmonary arterial hypertension with coexisting lung disease |
| Date of disclosure of the study information | 2024/10/31 |
| Last modified on | 2025/05/25 00:29:29 |
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Basic information
Public title
A non-interventional observational study evaluating the efficacy and safety of selexipag in pulmonary arterial hypertension with coexisting lung disease
Acronym
A non-interventional observational study evaluating the efficacy and safety of selexipag in pulmonary arterial hypertension with coexisting lung disease
Scientific Title
A non-interventional observational study evaluating the efficacy and safety of selexipag in pulmonary arterial hypertension with coexisting lung disease
Scientific Title:Acronym
A non-interventional observational study evaluating the efficacy and safety of selexipag in pulmonary arterial hypertension with coexisting lung disease
Region
| Japan |
Condition
Condition
Pulmonary arterial hypertension
Classification by specialty
| Cardiology | Pneumology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Pulmonary hypertension is a life-threatening disease with poor prognosis. Recently, there has been an increase in patients with pulmonary arterial hypertension coexisting with lung diseases such as emphysema and interstitial pneumonia. Although pulmonary vasodilators like PGI2 analogs, endothelin receptor antagonists, and PDE5 inhibitors have been developed, patients with comorbid lung diseases often exhibit treatment resistance, and further improvements in prognosis are anticipated. Selexipag (Uptravi), an oral PGI2 receptor agonist, is expected to be an effective treatment for pulmonary arterial hypertension with concomitant lung disease.
This study aims to evaluate clinical data from patients treated with selexipag, examining treatment approaches, efforts to improve prognosis, and multifaceted exploration of disease mechanisms, with the ultimate goal of providing recommendations for treatment guidelines in pulmonary hypertension with comorbid lung disease.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The changes in pulmonary vascular resistance (PVR) and 6-minute walk distance (6MWD) from baseline six months after initiating treatment with selexipag.
Key secondary outcomes
Changes of right heart catheterization parameters other than PVR, blood test findings (complete blood count, general biochemistry (AST, ALT, gGTP, LDH, ALP, total bilirubin, direct bilirubin, indirect bilirubin, BUN, creatinine, eGFR, free T3, free T4, TSH, total protein, albumin, sodium, potassium, chloride, calcium, magnesium, phosphorus), BNP, uric acid level, HbA1c, triglycerides, LDL cholesterol, HDL cholesterol, total cholesterol, high-sensitivity troponin T), echocardiography findings, pulmonary function test results, quality of life questionnaire, clinical observations (blood pressure, pulse, SpO2, respiratory rate, WHO functional class)
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
Individuals aged 18 or older who meet the diagnostic criteria for PAH on right heart catheterization at rest and who have hypoxemia associated with lung diseases such as chronic obstructive pulmonary disease, interstitial pneumonia, or mixed restrictive and obstructive disorders; or with conditions like sleep-disordered breathing, alveolar hypoventilation syndrome, chronic high-altitude exposure, or developmental disorders.
Patients are either receiving selexipag treatment or are being considered for it.
Key exclusion criteria
Patients who have not provided consent for the study or for whom selexipag administration is contraindicated (those with a history of hypersensitivity to selexipag, severe hepatic impairment, or pulmonary veno-occlusive disease).
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Ieda |
Organization
Keio University School of Medicine
Division name
Department of Cardiology
Zip code
160-8582
Address
35 Shinanomachi Shinjuku Tokyo Japan
TEL
03-5363-3373
mieda@keio.jp
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Hiraide |
Organization
Keio University School of Medicine
Division name
Department of Cardiology
Zip code
160-8582
Address
35 Shinanomachi Shinjuku Tokyo Japan
TEL
03-5363-3373
Homepage URL
t.hiraide.a6@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Nippon Shinyaku Co., Ltd.
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
Keio University School of Medicine
Address
35 Shinanomachi Shinjuku-ku Tokyo Japan
Tel
03-3353-1211
med-rinri-jimu@adst.keio.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 | 10 | Month | 31 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 07 | Month | 31 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 04 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 01 | 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
During the observation period of this study, the efficacy and safety of selexipag in real-world clinical practice will be evaluated. The following observational items, including treatment details and course of treatment for target cases, will be collected and analyzed from the Keio University Hospital Pulmonary Circulation Department's medical records. Nippon Shinyaku Co., Ltd. and the Department of Cardiology at Keio University Hospital will jointly prepare the study protocol and collaboratively interpret the collected and analyzed results. Baseline data will be defined as the most recent data obtained within eight weeks prior to the initiation of selexipag (date of selexipag initiation). Follow-up data will be defined as data obtained within eight weeks before or after 24 weeks from the selexipag initiation date.
Management information
Registered date
| 2024 | Year | 10 | Month | 31 | Day |
Last modified on
| 2025 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064005
