UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059714 |
|---|---|
| Receipt number | R000068297 |
| Scientific Title | The importance of microvascular dysfunction in patients with chronic thromboembolic pulmonary hypertension |
| Date of disclosure of the study information | 2025/11/17 |
| Last modified on | 2025/11/10 10:06:10 |
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Basic information
Public title
The importance of microvascular dysfunction in patients with chronic thromboembolic pulmonary hypertension
Acronym
Microcascular dysfunction in patients with CTEPH
Scientific Title
The importance of microvascular dysfunction in patients with chronic thromboembolic pulmonary hypertension
Scientific Title:Acronym
Microcascular dysfunction in patients with CTEPH
Region
| Japan |
Condition
Condition
Chronic thromboembolic pulmonary hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we will observe the degree of pulmonary microvascular dysfunction in CTEPH patients undergoing BPA treatment using a pressure wire and the CoroFlow Cardiovascular System. Since the effectiveness of BPA treatment strategies using this system has been reported in previous studies, the aim of this study is to deepen the understanding of the pathophysiology of pulmonary microvascular dysfunction from the data obtained during BPA treatment using this system. As mentioned above, there is currently no established index for quantifying the degree of pulmonary microcirculation. Using microcirculation indices obtained with a pressure wire and the CoroFlow Cardiovascular System, we aim to establish indicators that contribute to predicting post-BPA exercise tolerance and optimizing the distribution of pulmonary blood flow.
Basic objectives2
Others
Basic objectives -Others
None
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The following measurements will be performed three months after the final BPA: - Right heart catheterization (PAWP, PAP, RVP, RAP, CO, CI)- Exercise stress right heart catheterization (mPAP/CO slope, PAWP/CO slope)
Key secondary outcomes
1. Patient Basic Information: WHO-FC, emPHasis-10
2. Blood Test Results: Improvement in BNP and Nt-ProBNP
3. Imaging Results: Improvement in pulmonary blood flow on chest contrast CT and lung perfusion scintigraphy
4. Physiological Tests: Pulmonary function tests , transthoracic echocardiography, cardiopulmonary exercise test, 6-minute walk test
5. Blood Gas Tests (arterial, venous)
6. BPA Treatment Details (number of sessions, maximum balloon size, amount of contrast agent used, radiation exposure, fluoroscopy time)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients diagnosed with CTEPH
2. Patients judged eligible for BPA treatment
3. Patients aged 20 years or older at the time of obtaining consent
Key exclusion criteria
None
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Yamaguchi |
Organization
Osaka Metropolitan University Graduate School of Medicine
Division name
Cardiovascular Medicine
Zip code
545-8585
Address
1-4-3 Asahimachi, Abeno-ku, Osaka 545-8585, Japan
TEL
06-6645-3801
tomohiro.y.1987@gmail.com
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Yamaguchi |
Organization
Osaka Metropolitan University Graduate School of Medicine
Division name
Cardiovascular Medicine
Zip code
545-8585
Address
1-4-3 Asahimachi, Abeno-ku, Osaka 545-8585, Japan
TEL
06-6645-3801
Homepage URL
tomohiro.y.1987@gmail.com
Sponsor or person
Institute
Osaka Metropolitan University
Institute
Department
Personal name
Tomohiro Yamaguchi
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee of Osaka Metropolitan University Graduate School of Medicine
Address
6th Floor, Abeno Medics, 1-2-7 Asahimachi, Abeno Ward, Osaka City
Tel
06-6645-3456
gr-a-knky-ethics@omu.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
| 2025 | Year | 11 | Month | 17 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 10 | Month | 27 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 27 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 17 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2025 | Year | 11 | Month | 10 | Day |
Last modified on
| 2025 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068297
