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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
68
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
Beijing Chao-Yang Hospital
Beijing, China, China
RECRUITINGChina-Japan Friendship Hospital
Beijing, China, China
RECRUITINGBeijing Anzhen Hospital
Beijing, China, China
RECRUITINGChange 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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.