UMIN-CTR Clinical Trial

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

Chronic thromboembolic pulmonary hypertension (CTEPH)

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

medgrad@info.keio.ac.jp

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

Email

takayama@soiken.com

Institute

Department of Cardiology, Keio University School of Medicine

Institute

Department

Personal name

Organization

1. KANEKA MEDIX CORP.
2. Boston Scientific Japan K.K.

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

03

Month

14

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

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