Patients with Pulmonary Arterial Hypertension
Conditions
Interventions
Intervention Group:Chenodeoxycholic acid 250 mg twice daily for a total treatment duration of 16 weeks.
Sponsors
The First Affiliated Hospital of Xi’an Jiaotong University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Outpatients or inpatients from The First Affiliated Hospital of Xi’an Jiaotong University, meeting the following criteria: 1 Voluntary participation, with the patient or their authorized representative consenting to join the clinical trial and signing an informed consent form; 2 Age between 18 and 60 years, regardless of gender; 3 Screening criteria: echocardiography-estimated systolic pulmonary artery pressure (sPAP) > 50 mmHg; or prior right heart catheterization-confirmed mean pulmonary artery pressure (mPAP) > 25 mmHg, pulmonary capillary wedge pressure (PCWP) = 15 mmHg, and pulmonary vascular resistance (PVR) > 2 Wood units and < 10 Wood units. 4 Prior medication status: diagnosed with Group 1 pulmonary arterial hypertension (PAH) and treated with oral targeted therapies (including but not limited to macitentan, ambrisentan, or bosentan). Patients are considered to be in a stable phase if there is no significant change in echocardiography-measured systolic pulmonary artery pressure over a one-month period.
Exclusion criteria
Exclusion criteria: 1 Inability to sign the informed consent form; 2 Allergy to the drug(s); 3 Women who are currently pregnant or breastfeeding; 4 Acute infection, malignant diseases, bleeding disorders; 5 Chronic inflammation; infection with human immunodeficiency virus (HIV), hepatitis B or C; chronic diarrhea; 6 Complete biliary obstruction and severe hepatic impairment (Child-Pugh class C), with serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 times the upper limit of normal; 7 Severe renal impairment: serum creatinine > 2 times the upper limit of normal, or estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73m^ ²; 8 Currently participating in another clinical trial or study and taking investigational drugs, particularly immunosuppressants and other cholesterol-lowering therapies; 9 CT scan or pulmonary function tests indicating left heart disease or significant pulmonary disease; severe uncontrolled asthma, chronic obstructive pulmonary disease, eczema, atopic allergies, etc.; 10 Severe anemia that has not been corrected; 11 Suffering from non-cardiac diseases with an expected lifespan of < 2 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in 6-Minute Walk Distance; | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in cardiac functional class;Improvement in plasma NT-proBNP levels;Improvement in systolic pulmonary artery pressure measured by echocardiography; | — |
Countries
China
Contacts
Public ContactBeidi Lan
The First Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed