chronic thromboembolic pulmonary hypertension (CTEPH)
Conditions
Interventions
riociguat group:routine treatment and oral riociguat
Sponsors
Beijing Chao-Yang Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >=18 years old; 2.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; 3.Subjects had been treated with BPA and had received a stable dose of riociguat for >=12 weeks; 4.mPAP < 30mmHg; 5.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; 6.Subjects voluntarily sign written informed consent;
Exclusion criteria
Exclusion criteria: 1.Severe hepatic and renal insufficiency (Child-Pugh Grade C/creatinine clearance < 30ml/min·1.73m²); 2.The presence of severe infectious disease or severe bleeding tendency; 3.Combined with pulmonary hypertension of other types than CTEPH; 4.Other pulmonary hypertension targeting drugs are being used; 5.The expected survival time with cancer or other diseases is less than 6 months; 6.Pregnancy, lactation; 7.Subjects are currently participating in an interventional clinical trial; 8.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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cardiac output; | — |
Secondary
| Measure | Time frame |
|---|---|
| All-cause mortality, hypotension, clinical exacerbation of pulmonary hypertension leading to re-hospitalization or disability/incapacity;NT-proBNP, cardiac ultrasound, cardiac magnetic resonance non-invasive right heart structure and function evaluation index;The hemodynamic indicators such as pulmonary vascular resistance (PVR), mean pulmonary artery pressure (mPAP), etc., and oxygen kinetics indicators such as mixed venous oxygen saturation, etc.;6-minute walk test , WHO-FC, cardiopulmonary exercise test, SF-36 quality of life questionnaire; | — |
Countries
China
Contacts
Public ContactSuqiao Yang
Beijing Chao-Yang Hospital, Capital Medical University
Outcome results
None listed