Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
72 participants
INTERVENTIONAL
2020-10-16
2025-01-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Active Comparator: Active drug group Riociguat
Riociguat 0.5mg、1.0mg、2.5mg
Riociguat Oral Tablet
Take any dose of Riociguat from 0.5mg to 2.5mg, or placebo
Placebo group
Placebo 0.5mg、1.0mg、2.5mg
Riociguat Oral Tablet
Take any dose of Riociguat from 0.5mg to 2.5mg, or placebo
Interventions
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Riociguat Oral Tablet
Take any dose of Riociguat from 0.5mg to 2.5mg, or placebo
Eligibility Criteria
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Inclusion Criteria
2. Patients with diagnosed as a contraindication of pulmonary endarterectomy by an experienced surgeon in the central diagnosis
3. Patients who were adjusted to reach the appropriate dose of riociguat within 8 weeks and were able to continue riociguat thereafter
4. Patients who underwent BPA once or more after the dose adjustment of riociguat
5. Patients who have been able to continue taking the same dose of riociguat for more than 3 months
6. Patients who can obtain written informed consent from the patients and legal representatives
7. Patients with WHO functional class II or III at the time of the allocation
8. Over the age of 18 and under 85 at the time of obtaining informed consent
9. Patients with the resting CI value of less than 3.0 L/min/m2 in the right heart catheterization test immediately before the allocation
10. Patients with the mean pulmonary artery pressure less than 25 mmHg in a right heart catheterization test immediately before the allocation
Exclusion Criteria
2. Patients with pulmonary hypertension other than class 4 by NICE classification
3. Patients having difficulty in performing cardiopulmonary exercise test (CPET)
4. Patients with severe right heart failure requiring cardiotonic drugs
5. Patients with severe heart disease
6. Patients with severe liver damage
7. Patients with systolic blood pressure less than 90 mmHg at the screening
8. Patients with shunt disease
9. Patients with severe renal dysfunction (CCr \< 15 mL/min) requiring hemodialysis
10. Patients with life expectancy less than 2 years
11. Being pregnant or lactating
12. Patients who are contraindicated for riociguat
13. Patients using other unlicensed drugs
14. Patients who used pulmonary vasodilators within 4 weeks after obtaining the informed consent of the right heart catheterization test.
15. Patients whom the investigator determines that the participation in this study is inappropriate
18 Years
85 Years
ALL
No
Sponsors
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Bayer Yakuhin, Ltd.
INDUSTRY
National Hospital Organization Okayama Medical Center
OTHER
Responsible Party
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Principal Investigators
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Yutaka Ito
Role: STUDY_DIRECTOR
National Hospital Organization Nagoya Medical Center
Locations
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National Hospital Org anization Okayama Medical Center
Okayama, , Japan
Countries
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Central Contacts
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Facility Contacts
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References
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Galie N, Humbert M, Vachiery JL, Gibbs S, Lang I, Torbicki A, Simonneau G, Peacock A, Vonk Noordegraaf A, Beghetti M, Ghofrani A, Gomez Sanchez MA, Hansmann G, Klepetko W, Lancellotti P, Matucci M, McDonagh T, Pierard LA, Trindade PT, Zompatori M, Hoeper M; ESC Scientific Document Group. 2015 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension: The Joint Task Force for the Diagnosis and Treatment of Pulmonary Hypertension of the European Society of Cardiology (ESC) and the European Respiratory Society (ERS): Endorsed by: Association for European Paediatric and Congenital Cardiology (AEPC), International Society for Heart and Lung Transplantation (ISHLT). Eur Heart J. 2016 Jan 1;37(1):67-119. doi: 10.1093/eurheartj/ehv317. Epub 2015 Aug 29. No abstract available.
Ghofrani HA, D'Armini AM, Grimminger F, Hoeper MM, Jansa P, Kim NH, Mayer E, Simonneau G, Wilkins MR, Fritsch A, Neuser D, Weimann G, Wang C; CHEST-1 Study Group. Riociguat for the treatment of chronic thromboembolic pulmonary hypertension. N Engl J Med. 2013 Jul 25;369(4):319-29. doi: 10.1056/NEJMoa1209657.
Mizoguchi H, Ogawa A, Munemasa M, Mikouchi H, Ito H, Matsubara H. Refined balloon pulmonary angioplasty for inoperable patients with chronic thromboembolic pulmonary hypertension. Circ Cardiovasc Interv. 2012 Dec;5(6):748-55. doi: 10.1161/CIRCINTERVENTIONS.112.971077. Epub 2012 Nov 27.
Kataoka M, Inami T, Hayashida K, Shimura N, Ishiguro H, Abe T, Tamura Y, Ando M, Fukuda K, Yoshino H, Satoh T. Percutaneous transluminal pulmonary angioplasty for the treatment of chronic thromboembolic pulmonary hypertension. Circ Cardiovasc Interv. 2012 Dec;5(6):756-62. doi: 10.1161/CIRCINTERVENTIONS.112.971390. Epub 2012 Nov 6.
Shimokawahara H, Nishizaki M, Inami T, Kubota K, Taniguchi Y, Miyagi A, Kikuchi H, Goda A, Miyanaga S, Hashimoto H, Saito AM, Sekimizu M, Matsubara H. Effect of riociguat on exercise following balloon pulmonary angioplasty in patients with inoperable chronic thromboembolic pulmonary hypertension in Japan (THERAPY-HYBRID-BPA): a multicentre, double-blind, randomised, controlled, phase 4 trial. Lancet Respir Med. 2025 Sep;13(9):789-799. doi: 10.1016/S2213-2600(25)00127-4. Epub 2025 Jul 23.
Shimokawahara H, Inami T, Kubota K, Taniguchi Y, Hashimoto H, Saito AM, Sekimizu M, Matsubara H. Protocol for a multicentre, double-blind, randomised, placebo-controlled trial of riociguat on peak cardiac index during exercise in patients with chronic thromboembolic pulmonary hypertension after balloon pulmonary angioplasty (THERAPY-HYBRID-BPA trial). BMJ Open. 2023 Jul 5;13(7):e072241. doi: 10.1136/bmjopen-2023-072241.
Shimokawahara H, Ogawa A, Matsubara H. Balloon pulmonary angioplasty for chronic thromboembolic pulmonary hypertension: advances in patient and lesion selection. Curr Opin Pulm Med. 2021 Sep 1;27(5):303-310. doi: 10.1097/MCP.0000000000000797.
Other Identifiers
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Riociguat-CTEPH
Identifier Type: -
Identifier Source: org_study_id