A Phase 2 interventional study of Riociguat Oral Tablet in Hypertension, Pulmonary, sponsored by National Hospital Organization Okayama Medical Center. Status unknown at 1 site in Japan. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2020-10-23.
Sponsored by National Hospital Organization Okayama Medical Center · Phase 2, Interventional, and Supportive care
Riociguat could improve the exercise capacity and residual symptoms in patients with chronic thromboembolic pulmonary hypertension (CTEPH) even after normalization of pulmonary arterial pressure by balloon pulmonary angioplasty (BPA). This randomized controlled trial study aimed to clarify whether the improvement of peak cardiac index (CI) during exercise maintains or not between the riociguat continued group and the riociguat discontinued group.
CTEPH is a disease that causes progressive pulmonary hypertension due to stenoses or occlusions in the pulmonary artery due to an organized thrombus. And this is a disease that results in right heart failure and death unless early diagnosis and appropriate treatment are performed. Pulmonary endarterectomy (PEA), which surgically removes the intimal thrombus, has been established as the treatment of choice for CTEPH. In the AHA/ACC guideline and ESC guideline, PEA for CTEPH is class IC (1). In 2014, a soluble guanylate cyclase stimulant (generic name: riociguat), which is one of the therapeutic agents for pulmonary hypertension, was approved for patients with CTEPH who are ineligible for PEA, and residual pulmonary hypertension after PEA (2). In addition, it has been reported that BPA, which is a catheter interventional treatment, is also effective to improve hemodynamics in inoperable patients with CTEPH (3, 4). However, some patients have residual symptoms such as dyspnea on exertion even after normalization in hemodynamics by BPA. A randomized control study should be done to confirm the necessary of continuation of riociguat for such patients.
1,105 studies on the registry are indexed under Hypertension, Pulmonary; 234 are open to participants now.
This study's planned enrollment of 72 is above the median of 35 across 649 interventional studies indexed under Hypertension, Pulmonary.
Browse Hypertension, Pulmonary studies →This is the only study on the registry with National Hospital Organization Okayama Medical Center as lead sponsor.
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Exclusion Criteria:
Riociguat 0.5mg、1.0mg、2.5mg
Drug: Riociguat Oral Tablet
Placebo 0.5mg、1.0mg、2.5mg
Drug: Riociguat Oral Tablet
Take any dose of Riociguat from 0.5mg to 2.5mg, or placebo
Peak CI change
Change in Peak CI during the cardiopulmonary exercise test (CPET)
Time frame: from baseline to 16 weeks
This study is status unknown, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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