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

Sponsor
China National Center for Cardiovascular Diseases
Study ID
NCT06554301
Phase
PHASE1
Status
Recruiting
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Conditions

  • Pulmonary Arterial Hypertension

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • empagliflozin in treatment pulmonary aerterial hypertension — DRUG
    On the basis of background treatment, the experimental group was given 10 mg of empagliflozin tablets orally once a day for 12 weeks.
  • placebo in treatment pulmonary aerterial hypertension — DRUG
    On the basis of background treatment, the control group was given 10 mg of placebo tablets orally once a day for 12 weeks.

Study Details

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

Key Dates

Start date
Oct 20, 2024
Status verified
Aug 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
72 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: placebo in treatment pulmonary arterial hypertension
  • Experimental: empagliflozin in treatment pulmonary arterial hypertension

Primary Outcome Measure

6-minute walking distance [ Time Frame: From enrollment to the end of treatment at 12 weeks ]

Central Contacts

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