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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorChina National Center for Cardiovascular Diseases

About this trial

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

Qualifiers

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.

There are symptoms of WHO/NYHA FC Grade II or III.

Disqualifiers

1) Subjects shall not have the following three or more risk factors for left ventricular dysfunction: Body mass index (BMI)≥30 kg/m2 History of systemic hypertension

Trial design

Treatments tested in this trial

  • empagliflozin in treatment pulmonary aerterial hypertension
  • placebo in treatment pulmonary aerterial hypertension

Treatment groups

72 Participants
are divided into 2 treatment groups

Sponsors and collaborators

China National Center for Cardiovascular Diseases

Lead sponsor

The Second Hospital of Shandong University

Collaborator

The First People's Hospital of Changzhou

Collaborator