About this trial
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.
Eligibility criteria
Qualifiers
Age ≥18 years old
CTEPH was diagnosed and one of the following three factors was met: Pulmonary endarterectomy was technically impossible; Pulmonary endarterectomy is technically feasible, but the risk-benefit ratio is poor; Residual/recurrent pulmonary hypertension after pulmonary endarterectomy
Subjects had been treated with BPA and had received a stable dose of riociguat for ≥12 weeks
mPAP < 30mmHg
Disqualifiers
Severe hepatic and renal insufficiency (Child-Pugh Grade C/creatinine clearance < 30ml/min·1.73m²)
The presence of severe infectious disease or severe bleeding tendency
Combined with pulmonary hypertension of other types than CTEPH
Other pulmonary hypertension targeting drugs are being used
Trial design
Treatments tested in this trial
- Riociguat
- Routine Treatment
Treatment groups
Sponsors and collaborators
Suqiao Yang
Lead sponsor
Beijing Chao Yang Hospital
Sponsor institution
China-Japan Friendship Hospital
Collaborator
Beijing Anzhen Hospital
Collaborator