A Study on the Efficacy and Safety of Empagliflozin in the Treatment of Pulmonary Arterial Hypertension
The goal of this clinical trial is to learn if empagliflozin works to treat patients with pulmonary arterial hypertension. It will also learn about the safety of empagliflozin. The main questions it aims to answer are: Based on standard treatment, does empagliflozin reduce pulmonary artery pressure and improve cardiac function in patients with pulmonary arterial hypertension? What medical problems do participants have when taking empagliflozin? Researchers will compare empagliflozin to a placebo (a look-alike substance that contains no drug) to see if empagliflozin works to treat patients with pulmonary arterial hypertension. Participants will: Take empagliflozin or a placebo every day for 12 weeks Visit the clinic once every 4 weeks for checkups and tests Keep a diary of their symptoms and the drug taking situation
• At least 18 years old.
• Sign the informed consent form.
• Subjects who are willing and able to comply with the requirements of prescribed visits, treatment plans, laboratory examinations and other research procedures.
• PAH with symptoms was initially diagnosed and belonged to one of the following subgroups:
• A. Idiopathic pulmonary hypertension (IPAH); B. hereditary pulmonary hypertension (HPAH); C drug or toxin-induced PAH, based on previous exposure to drugs, chemicals or toxins, such as fenfluramine derivatives, other appetite suppressants, toxic rapeseed oil or L- tryptophan.
• D. PAH is accompanied by:
• A) connective tissue disease B) Congenital systemic-pulmonary shunt (surgical correction must be performed at least one year before screening, and there is no or no clinically insignificant systemic-pulmonary shunt \[1.0≤ lung-systemic blood flow ratio (QP/QS)≤1.5\]), according to the opinion of the researcher.
• Received right heart catheterization (RHC) at the time of screening or within 5 years before screening (if RHC is not performed, it will be performed during screening), which is consistent with the diagnosis of PAH and meets all the following criteria:
• A. mean pulmonary artery pressure (papm) \> 20mmhg (at rest) B pulmonary arteriole wedge pressure (PAWP)≤15 mmHg (if reliable PAWP data cannot be obtained, left ventricular end diastolic pressure \[LVEDP\]≤15 mmHg).
• C pulmonary vascular resistance (PVR) \> 2.00 wood units (\> 160 dynes/sec/cm5).
• There are symptoms of WHO/NYHA FC Grade II or III.
• Stable PAH targeted background oral therapy. Subjects received endothelin receptor antagonist (ERA) and/or phosphodiesterase inhibitor type 5 (PDE5-I) or soluble guanylate cyclase (sGC) agonist. Stability was defined as no change in dose or regimen within 30 days before baseline and during the duration of the study.
• 6-minute walking distance (6 MWD) ≥ 150m.
• If the subject is taking concomitant drugs that can affect PAH (for example, calcium channel blockers, digoxin or L- arginine supplements), the dose must be kept stable for at least 30 days before the baseline visit and throughout the study.
⁃ If there is the possibility of pregnancy, both male and female subjects should agree to use a highly effective contraceptive method during the whole study period (from informed consent to the end of follow-up).