Unique ID issued by UMIN | UMIN000019549 |
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Receipt number | R000022608 |
Scientific Title | Multicenter Randomized controlled trial based on Balloon Pulmonary Angioplasty for chronic thromboembolic pulmonary hypertension |
Date of disclosure of the study information | 2015/10/28 |
Last modified on | 2023/05/08 13:51:31 |
Multicenter Randomized controlled trial based on Balloon Pulmonary Angioplasty for chronic thromboembolic pulmonary hypertension
Multicenter Randomized controlled trial based on Balloon Pulmonary Angioplasty for chronic thromboembolic pulmonary hypertension
(MR BPA study)
Multicenter Randomized controlled trial based on Balloon Pulmonary Angioplasty for chronic thromboembolic pulmonary hypertension
Multicenter Randomized controlled trial based on Balloon Pulmonary Angioplasty for chronic thromboembolic pulmonary hypertension
(MR BPA study)
Japan |
Chronic thromboembolic pulmonary hypertension (CTEPH)
Cardiology |
Others
NO
To compare the efficacy and safety of riociguat with balloon pulmonary angioplasty (BPA) in the treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH) over the course of 12 months, to potentially aid in optimizing treatment selection and improving treatment outcomes
Safety,Efficacy
Change in the mean pulmonary arterial pressure from baseline to 12 months
1. Changes in the six-minute walk distance from baseline to 12 months
2. Changes in the Borg dyspnea index from baseline to 12 months
3. Changes in hemodynamic variables, including pulmonary vascular resistance (PVR), mean right arterial pressure, and cardiac output] from baseline to 12 months
4. Changes in the WHO functional class
5. Changes in plasma brain natriuretic peptide (BNP) levels from baseline to 12 months
6. Changes in arterial oxygen saturation (SaO2) and oxygen partial pressure (PaO2) from baseline to 12 months
7. Changes in the usage volume of oxygen therapy from baseline to 12 months, including commencing oxygen therapy due to the exacerbation of a primary disease or dosage change.
8. Changes in pulmonary function test parameters from baseline to 12 months
9. Changes in echocardiography test parameters from baseline to 12 months
10. Frequency and severity of pulmonary artery injury assessed by chest X-ray and chest computed tomography (CT) scan
11. Frequency of adverse events
12. Clinical worsening during the observation period and time to clinical worsening (TTCW)
13. Change in Quality of Life (QOL) parameters (EQ5D) from baseline to 12 months
14. Health insurance resource costs over 12 months
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
YES
Institution is considered as adjustment factor in dynamic allocation.
YES
Central registration
2
Treatment
Medicine |
Group A: BPA treatment
Basically BPA treatment needs to be
finished within 4 months from the day of first BPA session
Group B: Riociguat treatment
First, starting with riociguat 3 times per day (1.0mg/time). Then increase the dose by 0.5mg every two weeks (with systolic blood pressure 95mmHg or higher).
The maximum dose is 2.5mg per dose (three times per day). Dosage is adjusted accordingly for each patient, and the adjustment is finished within 4 months from the day of starting riociguat.
20 | years-old | <= |
80 | years-old | > |
Male and Female
Patients meeting the following criteria will be included in the study.
(a) patients who are diagnosed with CTEPH (based on the diagnostic criteria in the 2012 Japanese Circulation Society guidelines with a WHO functional class II or III).
(b) male and female aged >= 20 years and < 80 years.
(c) patients with mean pulmonary arterial pressure of >= 25 mmHg to < 60 mmHg and pulmonary artery wedge pressure of =< 15 mmHg.
(d) patients who undergo appropriate anticoagulant therapy for at least three months prior to consent acquisition (if warfarin is used, prothrombin time-international normalized ratio should be 1.5 to 3.0).
(e) patients who provide written consent form to participate in this study after full explanation of the study.
Patients meeting any of the following exclusion criteria will be excluded from the trial.
(a) patients with a history of BPA.
(b) patients who underwent PEA within six months prior to consent acquisition.
(c) patients who are using unapproved pharmaceutical products.
(d) patients who used a pulmonary vasodilator within four weeks prior to the right heart catheterization after consent acquisition.
(e) patients with co-existing etiology of pulmonary hypertension other than Group 4 in the Nice Pulmonary Hypertension Classification System.
(f) patients who are pregnant or breastfeeding.
(g) patients who met the contraindication for riociguat.
(h) patients whose life expectancy is less than two years.
(i) patients who are considered to be unsuitable for participation by investigators.
60
1st name | Keiichi |
Middle name | |
Last name | Fukuda |
Keio University School of Medicine
Department of Cardiology
160-8582
35 Shinanomachi, Shinjuku-ku, Tokyo,160-8582, Japan
03-3353-1211
medgrad@info.keio.ac.jp
1st name | Hiroki |
Middle name | |
Last name | Takayama |
Soiken, Inc.
Division of Clinical Study Support
101-0052
4th Floor, NBF Ogawa Bld., 1-3-1 Ogawamachi, Kanda, Chiyoda-ku, Tokyo, 101-0052, Japan
03-3295-1350
takayama@soiken.com
Keio University School of Medicine
Bayer Yakuhin, Ltd.
Profit organization
Japan
the Institutional Review Board of Keio University School of Medicine
35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan
03-5363-3611
med-rinri-jimu@adst.keio.ac.jp
NO
慶應大学医学部附属病院
2015 | Year | 10 | Month | 28 | Day |
https://bmjopen.bmj.com/content/10/2/e028831
Published
https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(22)00171-0/fulltext
61
By month 12, the mean PAP improved by -16.3+/-1.6mmHg in the BPA group, and -7.0+/-1.5mmHg in the riociguat group (group difference, -9.3 mmHg; 95% confidence interval -12.7 - -5.9, p<0.001). BPA group also demonstrated significant improvements in SaO2, PaO2, EQ-5D-3L, and functional class, whereas the cardiac output improved significantly in the riociguat group. The BPA related complication rate was 11.6%.
2023 | Year | 05 | Month | 08 | Day |
PA group
[Age (SD)] 68.0 (9.1)
[Sex (n)] male 7 / female 24
[Hight (cm (SD))] 156.4 (10.7)
[Body weight (kg (SD))] 58.2 (10.8)
[mean pulmonary arterial pressure (mmHg (SD))] 38.1 (7.9)
Riociguat group
[Age (SD)] 65.7 (10.9)
[Sex (n)] male 3 / female 23
[Hight (cm (SD))] 154.1 (7.1)
[Body weight (kg (SD))] 56.7 (11.2)
[mean pulmonary arterial pressure (mmHg (SD))] 37.5 (8.5)
October 15, 2015: Protocol approval by institutional review board
April 14, 2016: First subject in
February 28, 2019: Protocol approval by certified review board
August 6, 2019: Last subject in
September 25, 2020: Last subject last visit
The number of patients who experienced adverse event or the disease-or-the-like throughout the study period were as follows. The disease-or-the-like was defined as adverse event, of which the causal relationship to the study treatment (BPA or riociguat) was reported not to be able to be denied.
BPA group
[Death (n (%))] 0 (0.0)
[Adverse event (n (%))] 23 (71.9)
[Serious adverse event (n (%))] 5 (15.6)
[Disease-or-the-like (n (%))] 14 (43.8)
[Serious disease-or-the-like (n (%))] 1 (3.1)
Riociguat group
[Death (n (%))] 0 (0.0)
[Adverse event (n (%))] 18 (69.2)
[Serious adverse event (n (%))] 4 (15.4)
[Disease-or-the-like (n (%))] 13 (50.0)
[Serious disease-or-the-like (n (%))] 0 (0.0)
The disease-or-the-like, which occurred after the approval by the certified review board and publication in jRCT, were as follows;
BPA group
[Disease-or-the-like (n (%))] 6 (18.8)
[Serious disease-or-the-like (n (%))] 0 (0.0)
Riociguat group
[Disease-or-the-like (n (%))] 3 (11.5)
[Serious disease-or-the-like (n (%))] 0 (0.0)
<Primary endpoint>
Change in the mean pulmonary artery pressure from baseline to 12 months
<Secondary endpoint>
1. Changes in the six-minute walk distance from baseline to 12 months
2. Changes in the Borg dyspnea index from baseline to 12 months
3. Changes in hemodynamic variables, including pulmonary vascular resistance (PVR), mean right arterial pressure, and cardiac output] from baseline to 12 months
4. Changes in the WHO functional class
5. Changes in plasma brain natriuretic peptide (BNP) levels from baseline to 12 months
6. Changes in arterial oxygen saturation (SaO2) and oxygen partial pressure (PaO2) from baseline to 12 months
7. Changes in the usage volume of oxygen therapy from baseline to 12 months, including commencing oxygen therapy due to the exacerbation of a primary disease or dosage change.
8. Changes in pulmonary function test parameters from baseline to 12 months
9. Changes in echocardiography test parameters from baseline to 12 months
10. Frequency and severity of pulmonary artery injury assessed by chest X-ray and chest computed tomography (CT) scan
11. Frequency of adverse events
12. Clinical worsening during the observation period and time to clinical worsening (TTCW)
13. Change in Quality of Life parameters (EQ-5D-3L) from baseline to 12 months
14. Health insurance resource costs over 12 months
Completed
2015 | Year | 11 | Month | 17 | Day |
2015 | Year | 10 | Month | 15 | Day |
2016 | Year | 04 | Month | 01 | Day |
2020 | Year | 09 | Month | 25 | Day |
2021 | Year | 06 | Month | 24 | Day |
2022 | Year | 12 | Month | 31 | Day |
2015 | Year | 10 | Month | 28 | Day |
2023 | Year | 05 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022608
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