NCT06554301 A Study on the Efficacy and Safety of Empagliflozin in the Treatment of Pulmonary Arterial Hypertension
| NCT ID | NCT06554301 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | China National Center for Cardiovascular Diseases |
| Condition | Pulmonary Arterial Hypertension |
| Study Type | INTERVENTIONAL |
| Enrollment | 72 participants |
| Start Date | 2024-10-20 |
| Primary Completion | 2026-12 |
Trial Parameters
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Brief Summary
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
Eligibility Criteria
Inclusion Criteria: 1. At least 18 years old. 2. Sign the informed consent form. 3. Subjects who are willing and able to comply with the requirements of prescribed visits, treatment plans, laboratory examinations and other research procedures. 4. 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. 5. Received right heart catheterization (RHC) a