Chronic thromboembolic pulmonary hypertension
Conditions
Interventions
Placebo group of Lung Huoxue Capsule (Interventional Study):On top of conventional treatment, an oral placebo of Bu Fei Huo Xue Capsule (0.35 g, 4 capsules per dose, three times daily) is administered
Lung Replenishing and Huoxue Capsule Treatment Group (Interventional Study):On top of conventional treatment, oral Bu Fei Huo Xue Capsule (0.35 g per dose, 4 capsules per dose, three times daily) is a
Exposome (Cohort Study):None
Control group (cohort study):None
Sponsors
The First Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. RCT Studies: Inclusion Criteria: 1. Age>=18 years; 2. Confirmed diagnosis of CTEPH, and the mean pulmonary artery pressure was > 20mmHg and =18 years; 2. Patients with confirmed CTEPH and residual pulmonary hypertension after PEA or BPA, that is, the mean pulmonary artery pressure measured by right heart catheterization > 20mmHg; 3. Sign the informed consent form; 4. Qi deficiency and blood stasis syndrome
Exclusion criteria
Exclusion criteria: 1. RCT Studies: Exclusion Criteria: 1. Known or suspected hypersensitivity to the components of the study drug; 2. Participating in other drug clinical trials; 3. Pregnant and lactating females; 4. Patients with severe liver diseases (such as liver tumors, various types of hepatitis, etc.) or previous history of drug-induced liver injury; 5. According to the judgment of the investigator, those who are not suitable to participate in this trial. 2. Cohort Study: Exclusion Criteria: 1. Clear diagnosis of other types of pulmonary hypertension; 2. Anticipated inability to complete follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in peak oxygen uptake, as measured by cardiopulmonary exercise test, relative to baseline after 12 weeks of treatment.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in 6-minute walk distance from baseline after 12 weeks of treatment;Change in pulmonary vascular resistance from baseline, as measured by right heart catheterization after 12 weeks of treatment;Change in mean pulmonary arterial pressure from baseline, as measured by right heart catheterization after 12 weeks of treatment;Change in WHO functional class from baseline after 12 weeks of treatment; | — |
Countries
China
Contacts
Public ContactWang Tao
The First Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed