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
N/A
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
Researchers are evaluating empagliflozin to see if it can help treat patients with pulmonary arterial hypertension (PAH), a condition involving high blood pressure in the lungs' arteries. The study aims to find out if empagliflozin, when added to standard treatments, can reduce pulmonary artery pressure and improve heart function. It will also assess the safety of empagliflozin compared to a placebo, focusing on any medical problems participants may experience while taking the drug. Participants will be randomly assigned to receive either 10 mg of empagliflozin or a placebo tablet once daily for 12 weeks, along with their usual PAH treatments. The study is double-blinded, meaning neither the participants nor the researchers know who receives which treatment during the trial. Participants will visit the clinic every 4 weeks for check-ups and tests during the treatment period. During the study, participants will keep a diary to record symptoms and medication intake. Researchers will evaluate outcomes such as the distance walked in 6 minutes, heart function tests, lung blood flow measurements, quality of life, and heart imaging results. These assessments will be done from enrollment through the 12-week treatment period to monitor the effects and safety of empagliflozin.
CONDITIONS
Brief 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...
- At least 18 years old
- Signed informed consent form
- Willing and able to comply with visits, treatment plans, laboratory tests, and research procedures
- Diagnosed with symptomatic pulmonary arterial hypertension (PAH) in one of these subgroups: idiopathic, hereditary, drug/toxin-induced, or PAH with connective tissue disease or congenital systemic-pulmonary shunt (corrected at least one year prior)
- Right heart catheterization consistent with PAH diagnosis within 5 years or at screening, showing 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 PDE5 inhibitor or soluble guanylate cyclase agonist) with no dose changes 30 days before baseline and during study
- 6-minute walking distance 150 meters
- Stable doses of other PAH-related drugs for at least 30 days before baseline and during study
- Agreement to use effective contraception if pregnancy is possible during the study period
You will not qualify if you...
- Having three or more risk factors for left ventricular dysfunction such as BMI 30 kg/m2, history of systemic hypertension, or major coronary artery disease
- Mild or worse lung diseases shown by pulmonary function tests with FEV1 < 60% or total lung capacity < 60%
- Evidence of thromboembolic disease confirmed by lung ventilation/perfusion scan or standard diagnosis
- Severe chronic liver disease (Child-Pugh grade C), portal hypertension, cirrhosis, or related complications
- Active infection with hepatitis B or C virus
- Elevated liver enzymes (ALT or AST 3 times upper limit) or total bilirubin 2 times upper limit at screening
- Chronic kidney failure with serum creatinine > 2.5 mg/dL or needing dialysis
- Hemoglobin concentration < 9 g/dL
- Diabetes
- Cardiac function grade IV (NYHA)
- Prior treatment with intravenous or subcutaneous prostacyclin pathway drugs
- Pulmonary vein occlusion disease
- Malignant tumor diagnosis or treatment within 5 years, except certain skin or cervical cancers
- Alcohol or drug abuse history within 6 months
- Starting exercise-based cardiopulmonary rehab within 90 days before or during study
- Participation in other interventional clinical trials within 30 days before screening
- Allergic to empagliflozin or its components
- Life expectancy less than 12 months
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive either empagliflozin or placebo tablets once daily for pulmonary arterial hypertension as part of their treatment.
Weekly visits for up to 12 weeks
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
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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