Empagliflozin to improve left atrial function in people with paroxysmal atrial fibrillation, hypertension, and abnormal glucose metabolism

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, randomized, placebo-controlled Phase 2 trial will compare empagliflozin 10 mg once daily to placebo in adults with paroxysmal AF, hypertension, and abnormal glucose metabolism. Left atrial function will be measured at baseline and after 12 months using three-dimensional speckle-tracking echocardiography with blinded image acquisition and central blinded analysis at Huashan Hospital. Primary endpoints include changes in left atrial ejection fraction, volumes, and strain parameters, and secondary data will capture clinical events and safety. The trial enrolls patients without clinical heart failure or severe valvular disease and uses randomized allocation and blinding to minimize bias.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* • Patients aged 18-80 years, treated in the outpatient or inpatient departments of each research center and included in the AF database.

  * Patients with paroxysmal AF confirmed by 12-lead electrocardiogram, 24-hour Holter monitoring, or handheld electrocardiogram devices.
  * Patients with hypertension who have already started antihypertensive treatment.
  * Patients with diabetes who have already started antidiabetic treatment, or patients with prediabetes who have not received antidiabetic treatment but have an HbA1c level within the range of 6.1-6.4% in the past three months.

Exclusion Criteria:

* • Atrial fibrillation caused by severe mitral stenosis.

  * Atrial fibrillation with severe mitral regurgitation and severe tricuspid regurgitation.
  * Patients who have been clinically diagnosed with heart failure (heart failure with preserved ejection fraction or heart failure with reduced ejection fraction).
  * Special types of cardiomyopathy: amyloid cardiomyopathy, Fabry disease, muscular dystrophy, hypertrophic obstructive cardiomyopathy, etc.
  * Patients with a history of myocardial infarction within the past three months.
  * Pregnant women.

Where it's running

• Fudan University Affiliated Huashan Hospital, Cardiology Department
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Liwen Bao, MD
• Email: blw_betty@163.com
• Phone: 86 13917073226

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.