UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015855 |
|---|---|
| Receipt number | R000018410 |
| Scientific Title | Study on the improvement in exercise capacity in patients with inoperable chronic thromboembolic pulmonary hypertension who are treated with balloon pulmonary angioplasty |
| Date of disclosure of the study information | 2015/01/01 |
| Last modified on | 2021/09/09 16:30:55 |
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Basic information
Public title
Study on the improvement in exercise capacity in patients with inoperable chronic thromboembolic pulmonary hypertension who are treated with balloon pulmonary angioplasty
Acronym
Study on the improvement in exercise capacity in patients with inoperable chronic thromboembolic pulmonary hypertension who are treated with balloon pulmonary angioplasty
Scientific Title
Study on the improvement in exercise capacity in patients with inoperable chronic thromboembolic pulmonary hypertension who are treated with balloon pulmonary angioplasty
Scientific Title:Acronym
Study on the improvement in exercise capacity in patients with inoperable chronic thromboembolic pulmonary hypertension who are treated with balloon pulmonary angioplasty
Region
| Japan |
Condition
Condition
Chronic thromboembolic pulmonary hypertension
Classification by specialty
| Cardiology | Pneumology | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A purpose is to verify the improvement in exercise capacity in patients with chronic thromboembolic pulmonary hypertension who are treated with balloon pulmonary angioplasty adding to guanylate cyclase stimulant treatment
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Exercise capacity by cardiopulmonary exercise test
Key secondary outcomes
vascular endothelial function, sympton, hemodynamics by right heart catheterization, biomarkers by laboratory test
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 as inoperable chronic thromboembolic pulmonary hypertension
1-1 Pulmonary hypertension is confirmed with right heart catheterization (mean pulmonary arterial pressure is equal to or higher than 25 mmHg and pulmonary artery wedge pressure is equal to or less than 15 mmHg at rest).
1-2 Peripheral thrombus is confirmed in pulmonary artery in contrast CT or pulmonary angiography.
1-3 Segmental blood perfusion defect is comfirmed by ventilation-perfusion scintigraphy.
1-4 Inoperable judgement is performed by a surgeon with experience for pulmonary endarterectomy.
2. Patients with WHO functional class 2, 3 and 4
3. Patients who understand study details with written consents.
Key exclusion criteria
1. Pregnancy
2. History of allergic reaction to contrast medium
3. Cardiogenic shock
4. Severe liver dysfunction (Child-Pugh score C)
5. Renal dysfunction (serum creatinine levels is greater than or equal to 2.0 mg/dL)
6. Patients whose disadvantage in cardiopulmonary exercise test
(CPX) is greater than benefits among one with relative conraindications for CPX
7. Contraindications for CPX
8. Patients who cannot keep supine position
9. Left heart failure
10. Patients who have received balloon pulmonary angioplasty (BPA) at the point of entry
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kondo Takahisa |
Organization
Nagoya University Graduate School of Medicine
Division name
Advanced Medicine in Cardiopulmonary disease
Zip code
Address
Turumai-cho 65, Showa-ku, Nagoya 466-8560, Japan
TEL
052-744-0388
takahisa@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kondo Takahisa |
Organization
Nagoya University Graduate School of Medicine
Division name
Advanced Medicine in Cardiopulmonary disease
Zip code
Address
Turumai-cho 65, Showa-ku, Nagoya 466-8560, Japan
TEL
052-744-0388
Homepage URL
takahisa@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
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 | 01 | 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
Preinitiation
Date of protocol fixation
| 2014 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
BPA is added to medical therapy. Change of exercise capacity is evaluated.
Management information
Registered date
| 2014 | Year | 12 | Month | 05 | Day |
Last modified on
| 2021 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018410
