UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017191 |
|---|---|
| Receipt number | R000019944 |
| Scientific Title | Safety and efficacy of balloon pulmonary angioplasty for chronic thromboembolic pulmonary hypertension |
| Date of disclosure of the study information | 2015/05/01 |
| Last modified on | 2020/06/19 14:01:21 |
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Basic information
Public title
Safety and efficacy of balloon pulmonary angioplasty for chronic thromboembolic pulmonary hypertension
Acronym
BPA for CTEPH
Scientific Title
Safety and efficacy of balloon pulmonary angioplasty for chronic thromboembolic pulmonary hypertension
Scientific Title:Acronym
BPA for CTEPH
Region
| Japan |
Condition
Condition
Chronic thromboembolic pulmonary hypertension
Classification by specialty
| Medicine in general | Cardiology | Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the safety and efficacy of balloon pulmonary angioplasty for chronic thromboembolic pulmonary hypertension
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficacy: blood pressure, pulse rate, arterial blood gas analysis, echocardiography, pulmonary function test, right heart catheterization, 6-minute walk test, enhanced CT, pulmonary angiography
Safety: any adverse events (incidence, severity)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Balloon pulmonary angioplasty
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
Patients with chronic thromboembolic pulmonary hypertension who are symptomatic irrespective of the optimal medical treatment and not candidates for pulmonary endarterectomy
Key exclusion criteria
Those who do not meet the inclusion criteria
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ichizo Tsujino |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Internal Medicine
Zip code
Address
Kita 14, Nishi 5, Kita-ku, Sapporo
TEL
011-706-5911
itsujino@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ichizo Tsujino |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Internal Medicine
Zip code
Address
Kita 14, Nishi 5, Kita-ku, Sapporo
TEL
011-706-5911
Homepage URL
itsujino@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
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
| 2015 | Year | 05 | Month | 01 | 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
| 2013 | Year | 07 | Month | 17 | Day |
Date of IRB
| 2015 | Year | 12 | Month | 25 | Day |
Anticipated trial start date
| 2013 | Year | 07 | Month | 17 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 04 | Month | 20 | Day |
Last modified on
| 2020 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019944
