High-altitude pulmonary hypertension
Conditions
Interventions
Intervention Group:Receive Ambrisentan Treatment
Control Group:Receive Placebo Treatment
Sponsors
The Second Affiliated Hospital of the Army Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Individuals aged over 18 years who have resided in high-altitude areas (>= 2500 meters above sea level) for a long term (>= 6 months) and plan to stay for more than 1 year. 2. Borderline High-Altitude Pulmonary Hypertension: Resting mean pulmonary arterial pressure (mPAP) is > 20 mmHg and <= 30 mmHg, as detected by echocardiography. 3.Patients must voluntarily participate in this trial and sign the Informed Consent Form.
Exclusion criteria
Exclusion criteria: 1. Women who are pregnant, lactating, or planning to become pregnant within 1 year. 2. Pulmonary hypertension associated with congenital heart disease. 3.Severe hepatic or renal insufficiency (Child-Pugh Class C or estimated glomerular filtration rate [eGFR] < 30 mL/min). 4.Malignant tumors or life expectancy of less than 1 year. 5.Receiving other targeted drug therapies (e.g., phosphodiesterase type 5 inhibitors [PDE5i], endothelin receptor antagonists [ERA]); or if such therapies have been discontinued, the duration of discontinuation is < 4 weeks. 6.With contraindications to Ambrisentan or allergy to it. 7.Other circumstances assessed by the investigators as rendering the individual ineligible for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pulmonary Arterial Pressure Change from Baseline;24-Week Progression Rate of Borderline Pulmonary Hypertension (Defined as Mean Pulmonary Arterial Pressure> 30 mmHg, or Right Ventricular Function Impairment, or an Increase of >=1 Class in WHO Functi; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in SF-36 (Short Form 36-Item Health Survey) Score;Hospitalization due to pulmonary hypertension;Incidence rate of right heart function impairment (defined as reduction in FAC, S', or TAPSE from baseline);Progression rate of WHO-FC (World Health Organization Functional Class) functional classification, with an increase of >= 1 class considered as progression;Incidence Rate of Mean Pulmonary Arterial Pressure (mPAP) > 30 mmHg;Changes in Other Echocardiographic Parameters;all - cause mortality;Incidence Rate of Clinical Adverse Events/Adverse Reactions;Change in NT-proBNP levels; | — |
Countries
China
Contacts
Public ContactJun Jin
The Second Affiliated Hospital of the Army Medical University
Outcome results
None listed