Effect of Discontinuation of Riociguat on Right Heart Function in Patients With CTEPH After Combination Therapy
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 68
- 试验地点
- 3
- 主要终点
- Change from Baseline in the Cardiac Output at 6 Months.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •The expected survival time with cancer or other diseases is less than 6 months
- •Pregnancy, lactation
- •Subjects are currently participating in an interventional clinical trial
- •In the investigator's judgment, a subject's medical abnormality, physical condition, or medical history may affect his or her ability to participate in or complete the study
研究组 & 干预措施
riociguat group
The subject was given comprehensive treatment in accordance with the guidelines and oral riociguat.
干预措施: Riociguat (Drug)
routine treatment group
The subject was given comprehensive treatment in accordance with the guidelines.
干预措施: Routine Treatment (Drug)
结局指标
主要结局
Change from Baseline in the Cardiac Output at 6 Months.
时间窗: Baseline and 6-month follow-up
Cardiac Output was measured by right heart catheterization.
次要结局
- Change from Baseline in the concentration of NT-proBNP at 6 Months.(Baseline and 6-month follow-up)
- Change from Baseline in the Pulmonary Vascular Resistance at 6 Months.(Baseline and 6-month follow-up)
- Change from Baseline in the 6-minute walking distance at 6 Months.(Baseline, 3-month follow-up, and 6-month follow-up)
- 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(From the baseline to the completion follow-up,an average of 6 months)
研究者
Suqiao Yang
professor
Beijing Chao Yang Hospital