RecruitingPhase 1NCT06554301

A Study on the Efficacy and Safety of Empagliflozin in the Treatment of Pulmonary Arterial Hypertension


Sponsor

China National Center for Cardiovascular Diseases

Enrollment

72 participants

Start Date

Oct 20, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether empagliflozin — a drug originally used for type 2 diabetes and heart failure — can also benefit patients with pulmonary arterial hypertension (PAH), a serious condition where high pressure in the blood vessels of the lungs strains the heart. Patients will take empagliflozin on top of their existing PAH medications. **You may be eligible if...** - You are 18 or older with a confirmed PAH diagnosis (verified by right heart catheterization) - Your PAH is from an idiopathic, hereditary, drug-induced cause, or is associated with connective tissue disease or certain congenital heart conditions - You are on stable PAH medications (endothelin receptor antagonists, PDE5 inhibitors, or sGC stimulators) - You can walk at least 150 meters in 6 minutes **You may NOT be eligible if...** - You have diabetes - Your PAH is caused by a blood clot in the lungs (chronic thromboembolic disease) - You have severe liver disease, significant kidney dysfunction (creatinine > 2.5 mg/dL), or low hemoglobin - You are pregnant or breastfeeding - You have already received IV or SC prostacyclin medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGempagliflozin in treatment pulmonary aerterial hypertension

On the basis of background treatment, the experimental group was given 10 mg of empagliflozin tablets orally once a day for 12 weeks.

DRUGplacebo in treatment pulmonary aerterial hypertension

On the basis of background treatment, the control group was given 10 mg of placebo tablets orally once a day for 12 weeks.


Locations(1)

Fuwai Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

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NCT06554301


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