Pulmonary Hypertension Secondary to Bronchiectasis
Conditions
Interventions
Treatment Group Receiving the Study Drug:Beraprost Sodium Sustained?release Tablets
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years; 2. Confirmed diagnosis of bronchiectasis-associated pulmonary hypertension (severe) by right heart catheterization (RHC) within the past 1 year, defined as: mean pulmonary arterial pressure (mPAP) > 20 mmHg at rest, pulmonary capillary wedge pressure (PAWP) = 5 Wood units (WU); 3. Definitive diagnosis of bronchiectasis by chest CT within the past 6 months, with other types of pulmonary hypertension excluded; 4. The underlying lung disease is in a clinically stable period (i.e., no acute exacerbation within the 4 weeks prior to enrollment, and stable disease status); 5. Baseline 6-minute walking distance (6MWD) >= 100 meters; 6. Ability to understand the study requirements and provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Diagnosis of other types of pulmonary hypertension (PH); 2. Known hypersensitivity to beraprost sodium sustained-release tablets or any of their excipients; 3. Use of other PAH-targeted therapies within 30 days; 4. Severe hepatic dysfunction (Child-Pugh Class C) or severe renal impairment (eGFR < 30 mL/min/1.73 m^2); 5. Active bleeding or a high risk of bleeding disorders; 6. Severe left heart disease (LVEF < 40%, severe valvular heart disease); 7. Myocardial infarction, unstable angina, or stroke within 3 months prior to screening; 8. Systolic blood pressure < 90 mmHg; 9. Severe hypoxemia (SpO2 < 85% at rest while breathing room air, or requiring high-flow oxygen therapy); 10. Pregnancy, lactation, or planned pregnancy during the study period (women of childbearing potential must use effective contraception); 11. Any condition that, in the investigator's judgment, may interfere with study assessments, increase the subject's risk, or affect compliance (e.g., malignancy, severe psychiatric illness, substance abuse, or life expectancy < 6 months).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6?minute walking distance; | — |
Secondary
| Measure | Time frame |
|---|---|
| NT-proBNP;Borg Dyspnea Scale;Laboratory test indicators and incidence of electrocardiogram abnormalities;Modified Medical Research Council Dyspnea Scale;Incidence of adverse events (AE) and serious adverse events (SAE);Mental Health Scale;Quality of Life Questionnaire Assessment;Vital Signs;Hemodynamics;Time of clinical deterioration;WHO Functional Classification; | — |
Countries
China
Contacts
Public ContactLan Wang
Shanghai Pulmonary Hospital
Outcome results
None listed