Health TrialsbyHealthPanel

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

ConditionPulmonary 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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: placebo in treatment pulmonary arterial hypertensionPlacebo comparator 1 intervention
Group B: empagliflozin in treatment pulmonary arterial hypertensionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

6-minute walking distance

6-minute walking distance

Time frame
From enrollment to the end of treatment at 12 weeks

Secondary outcomes

1

Clinical deterioration event

Clinical deterioration event

Time frame
From enrollment to the end of treatment at 12 weeks
2

Cardiac function index(NT-proBNP, WHO functional classification)

Cardiac function index(NT-proBNP, WHO functional classification)

Time frame
From enrollment to the end of treatment at 12 weeks
3

Hemodynamic index

Hemodynamic index

Time frame
From enrollment to the end of treatment at 12 weeks
4

Health-related quality of life (HRQoL) index

Health-related quality of life (HRQoL) index

Time frame
From enrollment to the end of treatment at 12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

China National Center for Cardiovascular Diseases

Lead sponsor

The Second Hospital of Shandong University

Collaborator

The First People's Hospital of Changzhou

Collaborator

Source ClinicalTrials.gov
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