A Phase 3 interventional study of Riociguat and Routine Treatment in Chronic Thromboembolic Pulmonary Hypertension, sponsored by Suqiao Yang. Recruiting at 3 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-30.
Sponsored by Suqiao Yang · Phase 3, Interventional, and Treatment
Riociguat and balloon pulmonary angioplasty (BPA) are established standard-of-care interventions for inoperable chronic thromboembolic pulmonary hypertension (CTEPH) with comparable evidence levels. However, the optimal combined treatment strategy remains unclear. Specifically, there is no consensus on whether riociguat should be continued long-term after achieving hemodynamic stability with BPA. Additionally, the long-term effects of riociguat discontinuation on right ventricular (RV) structure and function remain poorly characterized, particularly due to the lack of comprehensive noninvasive evaluations integrating cardiac magnetic resonance (CMR) and echocardiography. This prospective study aims to determine the hemodynamic impact of riociguat discontinuation in inoperable CTEPH patients who have achieved BPA treatment endpoints using right heart catheterization (RHC). Evaluate RV remodeling and functional changes after riociguat cessation through multimodal noninvasive imaging (CMR, echocardiography). Assess safety outcomes and identify potential rebound pulmonary hypertension or decompensated RV dysfunction associated with riociguat withdrawal.
1,105 studies on the registry are indexed under Hypertension, Pulmonary; 234 are open to participants now.
This study's planned enrollment of 68 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 Suqiao Yang as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The subject was given comprehensive treatment in accordance with the guidelines and oral riociguat.
Drug: Riociguat
The subject was given comprehensive treatment in accordance with the guidelines.
Drug: Routine Treatment
On the basis of the comprehensive treatment in line with the guidelines, including conventional diuresis, anticoagulation, oxygen inhalation, etc., continue oral administration of riociguat for treatment.
On the basis of the comprehensive treatment in line with the guidelines, including conventional diuresis, anticoagulation, oxygen inhalation, etc, and stop taking riociguat
Change from Baseline in the Cardiac Output at 6 Months.
Cardiac Output was measured by right heart catheterization.
Time frame: Baseline and 6-month follow-up
Change from Baseline in the Pulmonary Vascular Resistance at 6 Months.
Pulmonary Vascular Resistance was measured by right heart catheterization.
Time frame: Baseline and 6-month follow-up
Change from Baseline in the concentration of NT-proBNP at 6 Months.
The concentration of NTproBNP in serum was detected in pg/ml
Time frame: Baseline and 6-month follow-up
Change from Baseline in the 6-minute walking distance at 6 Months.
6-minute walking distance was measured by 6-minute walking test
Time frame: Baseline, 3-month follow-up, and 6-month follow-up
All-cause mortality
Observe and record All-cause mortality
Time frame: From the baseline to the completion follow-up,an average of 6 months
Combined incidence of all-cause death, re-hospitalization or disability/incapacity events due to clinical exacerbation of pulmonary hypertension
Observe and record All-cause mortality, clinical exacerbation of pulmonary hypertension leading to re-hospitalization or disability/incapacity
Time frame: From the baseline to the completion follow-up,an average of 6 months
Plan to share: No
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