UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021466 |
|---|---|
| Receipt number | R000024760 |
| Scientific Title | Multicenter randomized controlled trial based on balloon pulmonary angioplasty for chronic thromboembolic pulmonary hypertension: Sub study (MR BPA Sub Study) |
| Date of disclosure of the study information | 2016/03/14 |
| Last modified on | 2023/03/20 10:53:21 |
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Basic information
Public title
Multicenter randomized controlled trial based on balloon pulmonary angioplasty for chronic thromboembolic pulmonary hypertension: Sub study (MR BPA Sub Study)
Acronym
Multicenter Randomized controlled trial based on Balloon Pulmonary Angioplasty for chronic thromboembolic pulmonary hypertension: Sub study (MR BPA Sub Study)
Scientific Title
Multicenter randomized controlled trial based on balloon pulmonary angioplasty for chronic thromboembolic pulmonary hypertension: Sub study (MR BPA Sub Study)
Scientific Title:Acronym
Multicenter Randomized controlled trial based on Balloon Pulmonary Angioplasty for chronic thromboembolic pulmonary hypertension: Sub study (MR BPA Sub Study)
Region
| Japan |
Condition
Condition
Chronic thromboembolic pulmonary hypertension (CTEPH)
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This is a sub study of MR BPA (Multicenter randomized controlled trial based on balloon pulmonary angioplasty for chronic thromboembolic pulmonary hypertension). Of the operable patients judged in MR BPA study, we investigate the treatment actually given to them and the efficacy of it in order to establish treatment tactics.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in average pulmonary artery pressure from baseline to 12 months
Key secondary outcomes
1. Change in the 6-minute walk distance (6MWD) from baseline to 12 months
2. Change in Borg Dyspnea Index from baseline to 12 months
3. Change in a hemodynamic index (pulmonary vascular resistance, average right atrial pressure, and cardiac output) from baseline to 12 months
4. Change of WHO functional classification
5. Change of plasma BNP concentration
6. Change in SaO2 and PaO2 from baseline to 12 months
7. Change in use of oxygen therapy (including initiation of oxygen therapy for deteriorated iatrogenic disease and change of the amount of use)
8. Change in each parameter of pulmonary function test at 12 months
9. Change in each parameter of echocardiography at 12 months
10. Frequency and severity of lung injury determined by chest X-ray and CT images
11. Occurrence of adverse events
12. Time to clinical worsening (TTCW) during the observation period
13. Change in QOL (EQ5D-3L) parameters
14. Expense of the health insurance resources during the 12 months
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who meet all of the following criteria are included:
1. Meet the CTEPH standard (based on the Japanese Circulation Society 2012 guideline)
2. Patients with class II or III of the WHO functional classification
3. Patients who are at age of 20 or older and younger than 80 years old at the time of giving their written consent
4. After consenting, average pulmonary artery pressure at right artery catheterization (RHC) checkup after giving their consent is 25mmHg or higher and below 60mmHg with pulmonary artery wedge pressure of 15mmHg or lower
5. Patients who have been on an appropriate anticoagulant therapy (PT-INR of 1.5 to 3.0) for three months or longer before consenting
6. Patients who are capable of providing their written consent
Key exclusion criteria
Patients who meet any of the
following criteria are excluded:
1. With a history of BPA treatment
2. Patients underwent PEA within 6 months before giving their written consent
3. Currently using any unapproved medicine (by Japanese authorities).
4. Patients who used any pulmonary vasodilatation agents within 4 weeks before RHC checkup after giving consent
5. Complicated with pulmonary hypertension but are not type IV of Nice classification
6. Pregnant or breastfeeding
7. Patients who are prohibited to use riociguat
8. Life expectancy less than 2 years
9. Patients who are judged by physicians/investigators to be inappropriate to participate in the study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Prof. Keiichi Fukuda |
Organization
Keio University School of Medicine
Division name
Department of Cardiology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan 160-8582
TEL
03-3353-1211
medgrad@info.keio.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroki Takayama |
Organization
Soiken Inc.
Division name
Division of Clinical Study Support
Zip code
Address
4th Floor, NBF Ogawa Bld., 1-3-1 Ogawamachi, Kanda, Chiyoda-ku, Tokyo, Japan 101-0052
TEL
03-3295-1350
Homepage URL
takayama@soiken.com
Sponsor or person
Institute
Department of Cardiology, Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
1. KANEKA MEDIX CORP.
2. Boston Scientific Japan K.K.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 03 | Month | 14 | 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
| 2016 | Year | 01 | Month | 17 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a sub study of MR BPA (Multicenter randomized controlled trial based on balloon pulmonary angioplasty for chronic thromboembolic pulmonary hypertension). Of all operable patients judged in MR BPA study starting in January of 2016, we evaluate the treatment actually given to the patients and the efficacy of it in this observational study.
Management information
Registered date
| 2016 | Year | 03 | Month | 14 | Day |
Last modified on
| 2023 | Year | 03 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024760
