chronic thromboembolic pulmonary hypertension, CTEPH
Conditions
Interventions
Diltiazem Hydrochloride: AVT-positive group:Treatment of Patients with Chronic Thromboembolic Pulmonary Hypertension Using Diltiazem Hydrochloride.
Riociguat group: AVT-negative group:Treatment of Patients with Chronic Thromboembolic Pulmonary Hypertension Using Riociguat.
Sponsors
Beijing Chao-Yang Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Meets the diagnostic criteria for CTEPH both in China and internationally (at least two imaging methods must be used to confirm pulmonary artery thrombosis: ventilation-perfusion scanning, pulmonary angiography, or spiral CT pulmonary angiography; at least 3 months of standard anticoagulant therapy; hemodynamics: at rest, a right heart catheterization measurement of mPAP > 20 mmHg and PAWP <= 15 mmHg. 2.Determined by a multidisciplinary team, including at least one cardiothoracic surgeon, that surgery is technically unfeasible, or the patient has persistent or recurrent pulmonary hypertension after undergoing pulmonary endarterectomy. 3.18 to 80 years old. 4.6-minute walk distance of 150 to 450 meters. 5.Voluntarily participate in this study and sign the informed consent form. 6.Does not meet any exclusion criteria.
Exclusion criteria
Exclusion criteria: 1.Baseline blood pressure below 90/60 mmHg. 2.The patient has received endothelin receptor antagonists, prostacyclin analogs, phosphodiesterase type 5 inhibitors, or nitric oxide donors within 3 months prior to the start of the study. 3.Pregnant or breastfeeding women. 4.Disagree to enter the clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of the population with a decrease in pulmonary vascular resistance of >20% after 16 weeks of treatment.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hemodynamic data(Pulmonary vascular resistance, pulmonary artery pressure, cardiac output, cardiac index);6-minute walk distance;NT-proBNP;World Health Organization (WHO) functional class;Right ventricular base inner diameter, estimated pulmonary artery systolic pressure, and other related indicators;Occurrence of clinical worsening events (during the observation period: all-cause mortality, heart/lung transplantation, salvage pulmonary endarterectomy, initiation of CTEPH-related interventions or;Total cost of the investigational treatment drug;Adverse events;Borg dyspnea scale;Arterial partial pressure of oxygen;SvO2; | — |
Countries
China
Contacts
Public ContactJifeng Li
Beijing Chao-Yang Hospital, Capital Medical University
Outcome results
None listed