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

A Randomized Controlled Trial of SGLT2 Inhibitors to Improve Left Atrial Function in Patients With Paroxysmal Atrial Fibrillation and Comorbid Hypertension and Abnormal Glucose Metabolism

This trial tests whether taking empagliflozin once daily for 12 months can improve left atrial function in adults with paroxysmal atrial fibrillation, hypertension, and diabetes or prediabetes.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 66 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Huashan Hospital (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07482020 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults 18–80 years old with documented paroxysmal atrial fibrillation, treated hypertension, and diabetes or prediabetes (including HbA1c 6.1–6.4% for untreated prediabetes) without clinical heart failure or severe valvular disease.

Not a fit: People with clinical heart failure, permanent AF, severe mitral or tricuspid valve disease, certain cardiomyopathies (e.g., cardiac amyloidosis), or those unable to attend follow-up at the participating Shanghai centers are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, empagliflozin could improve left atrial mechanics and potentially lower the risk of AF-related heart failure in this high-risk population.

How similar studies have performed: Large SGLT2 inhibitor trials have shown reduced heart‑failure events and a lower incidence of new-onset AF, but randomized data specifically showing improvement in left atrial function are limited.

Eligibility criteria

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 this trial is running

Shanghai, Shanghai Municipality

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

Study contacts

• Study coordinator: Liwen Bao, MD

Conditions Atrial Fibrillation; Hypertension; SGLT2 inhibitor; atrial fibrillation; hypertension