Effect of SGLT2 Inhibition With Empagliflozin on Atrial Fibrillation Severity (SWEET-AF)

Effect of SGLT2 Inhibition With Empagliflozin on Atrial Fibrillation Severity in overweight adults (SWEET-AF)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12621000208808

Acronym

SWEET-AF

Enrollment

278

Registered

2021-02-26

Start date

2021-04-15

Completion date

Unknown

Last updated

2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Atrial fibrillation (AF) is the most common arrhythmia in Australia and confers a significant risk of stroke, heart failure and death. Furthermore, patients with symptomatic AF represent a growing burden on the Australian healthcare system. In view of this epidemic, new approaches to preventing and managing the symptoms and complications of AF are required. Sodium-glucose co-transporter-2 (SGLT2) inhibitors are new class of medications designed with diabetes in mind via the renal excretion of glucose. However, in addition to lowering blood glucose, these agents also appear to have significant pleiotropic effects on multiple cardiometabolic factors that are associated with AF.There is strong rationale for the potential benefit of SGLT2 inhibition in patients with AF. However, this class of medications have not been previously tested in these individuals. This study is a Phase II, investigator-initiated, multicenter, randomised controlled trial, investigating the use of Empagliflozin, a SGLT2 inhibitor in patients with AF. It is anticipated that SGLT2 inhibition with Empagliflozin will significantly reduce AF symptoms and arrhythmia burden. A total of 300 participants with symptomatic paroxysmal or persistent AF will be recruited and randomised in 1:1 ratio to Empagliflozin or Placebo. Participants will attend follow up clinic visits every 3 months for a 1-year period.

Interventions

A total of 300 individuals with symptomatic paroxysmal or persistent AF will be randomised in 1:1 ratio to Empagliflozin or Placebo for a total of 12 months. Empagliflozin tablets and respective placebo tablets will be identical in size, colour, smell and taste. The bottles of study medication will be labelled with unique identification numbers. Participants will take one tablet daily. The dose of Empagliflozin is 10 miligrams. Medication adherence will be ascertained by drug tablet return.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

• At least 18 years of age • Symptomatic paroxysmal or persistent AF (in sinus rhythm at time of enrolment) • Body mass index (BMI) > 27 • NB: A history of diabetes is not required for inclusion

Exclusion criteria

• Current or prior use of SGLT2 inhibitor • Not on stable glucose-lowering regimen for 12 weeks if diabetic • Estimated glomerular filtration rate < 30ml/min/1.73m2 • Acute, decompensated heart failure • Women pregnant, nursing, or who plan to become pregnant during trial period • Contraindication to CMR (implanted cardiac devices, cochlear implants, intracranial metallic implants and claustrophobia). • Inability to provide informed consent

Outcome results