Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| China-Japan Friendship Hospital | OTHER |
| Beijing Anzhen Hospital | OTHER |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| riociguat group | Active Comparator | The subject was given comprehensive treatment in accordance with the guidelines and oral riociguat. |
|
| routine treatment group | Experimental | The subject was given comprehensive treatment in accordance with the guidelines. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Riociguat | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in the Cardiac Output at 6 Months. | Cardiac Output was measured by right heart catheterization. | Baseline and 6-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in the Pulmonary Vascular Resistance at 6 Months. | Pulmonary Vascular Resistance was measured by right heart catheterization. | Baseline and 6-month follow-up |
| Change from Baseline in the concentration of NT-proBNP at 6 Months. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Suqiao Yang | Contact | 010-85231217 | yangsuqiao@126.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Chao-Yang Hospital | Recruiting | Beijing | China | 100020 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C542595 | riociguat |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Routine Treatment | Drug | On the basis of the comprehensive treatment in line with the guidelines, including conventional diuresis, anticoagulation, oxygen inhalation, etc, and stop taking riociguat |
|
The concentration of NTproBNP in serum was detected in pg/ml
| 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 | Baseline, 3-month follow-up, and 6-month follow-up |
| All-cause mortality | Observe and record All-cause mortality | 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 | From the baseline to the completion follow-up,an average of 6 months |
| China-Japan Friendship Hospital | Recruiting | Beijing | China | 100029 | China |
|
| Beijing Anzhen Hospital | Recruiting | Beijing | China | 101118 | China |
|