Effect of Discontinuation of Riociguat on Right Heart Function in Patients With CTEPH After Combination Therapy

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

• Male subjects and female subjects of reproductive age are required to use effective contraception for at least 28 days after signing the informed consent form. Male subjects are not allowed to donate sperm and female subjects are not allowed to breastfeed.

• Subjects voluntarily sign written informed consent

Locations
Other Locations
China
Beijing Anzhen Hospital
RECRUITING
Beijing
Beijing Chao-Yang Hospital
RECRUITING
Beijing
China-Japan Friendship Hospital
RECRUITING
Beijing
Contact Information
Primary
Suqiao Yang
yangsuqiao@126.com
010-85231217
Time Frame
Start Date: 2025-03-21
Estimated Completion Date: 2027-10-31
Participants
Target number of participants: 68
Treatments
Active_comparator: riociguat group
The subject was given comprehensive treatment in accordance with the guidelines and oral riociguat.
Experimental: routine treatment group
The subject was given comprehensive treatment in accordance with the guidelines.
Sponsors
Collaborators: Beijing Anzhen Hospital, China-Japan Friendship Hospital
Leads: Suqiao Yang

This content was sourced from clinicaltrials.gov