Actively Recruiting
A Study on the Efficacy and Safety of Empagliflozin in the Treatment of Pulmonary Arterial Hypertension
Led by China National Center for Cardiovascular Diseases · Updated on 2026-03-19
72
Participants Needed
1
Research Sites
110 weeks
Total Duration
On this page
Sponsors
C
China National Center for Cardiovascular Diseases
Lead Sponsor
T
The Second Hospital of Shandong University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
A Study on the Efficacy and Safety of Empagliflozin in the Treatment of Pulmonary Arterial Hypertension
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Signed informed consent form
- Willing and able to follow visit schedules, treatments, lab tests, and other study procedures
- Diagnosed with symptomatic pulmonary arterial hypertension (PAH) of specified subtypes including idiopathic, hereditary, drug-induced, connective tissue disease-associated, or congenital systemic-pulmonary shunt corrected at least 1 year prior
- Right heart catheterization confirming PAH diagnosis with mean pulmonary artery pressure >20 mmHg, pulmonary arteriole wedge pressure 15 mmHg, and pulmonary vascular resistance >2.00 Wood units
- WHO/NYHA functional class II or III symptoms
- Stable PAH oral background therapy (endothelin receptor antagonist and/or phosphodiesterase type 5 inhibitor or soluble guanylate cyclase agonist) with no dose changes 30 days before and during the study
- 6-minute walking distance of at least 150 meters
- Stable dose of any concomitant drugs affecting PAH for at least 30 days before and throughout the study
- Agreement to use highly effective contraception if pregnancy is possible during the study period
You will not qualify if you...
- Presence of three or more risk factors for left ventricular dysfunction including BMI 30 kg/m2 and history of systemic hypertension
- History or evidence of major coronary artery disease such as myocardial infarction, coronary intervention, bypass surgery, or stable angina
- Lung diseases with FEV1 <60% or total lung volume <60% of expected value within 180 days before or during screening
- Evidence of thromboembolic disease confirmed by ventilation/perfusion scan or standard diagnosis
- Severe chronic liver disease (Child-Pugh grade C), portal hypertension, cirrhosis, or related complications
- Active hepatitis B or C infection
- Elevated liver enzymes (ALT or AST 3 times upper limit) or bilirubin 2 times upper limit at screening
- Chronic kidney failure defined as serum creatinine >2.5 mg/dL or requiring dialysis
- Hemoglobin less than 9 g/dL at screening
- Diagnosis of diabetes
- Cardiac function NYHA class IV
- Prior treatment with intravenous or subcutaneous prostacyclin pathway drugs before baseline
- Pulmonary vein occlusion disease
- Malignant tumor diagnosed or treated within 5 years except certain skin or cervical cancers
- History of alcohol or drug abuse within 6 months
- Started exercise-based cardiopulmonary rehabilitation within 90 days before or during study
- Participation in other interventional clinical trials within 30 days before screening
- Known allergy to empagliflozin or its components
- Life expectancy less than 12 months as judged by researcher
- Pregnant or lactating women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100037
Actively Recruiting
Research Team
T
Tingting Guo, M.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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