RecruitingPhase 2ACTRN12621000208808

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)


Sponsor

The University of Adelaide

Enrollment

300 participants

Start Date

Apr 15, 2021

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Atrial fibrillation (AF) is the most common heart rhythm disorder in Australia. It causes the heart to beat irregularly, which can lead to stroke, heart failure, and a significantly reduced quality of life. Managing AF symptoms remains a major challenge, and researchers are always looking for new treatment approaches. This study, called SWEET-AF, is investigating whether a medication called empagliflozin — originally developed for type 2 diabetes — can help reduce the frequency and severity of AF episodes. Empagliflozin belongs to a class of drugs called SGLT2 inhibitors, which have shown surprising benefits for the heart beyond just controlling blood sugar. You do not need to have diabetes to participate. To be eligible, you need to be 18 or older, have symptomatic paroxysmal or persistent AF (currently in normal sinus rhythm), and have a body mass index over 27. In this Phase 2 trial, 300 participants will be randomly assigned to receive either empagliflozin or a placebo for one year, with clinic visits every three months. Researchers are hoping this medication will significantly reduce AF symptoms and how often episodes occur. The trial is being run across multiple centres in Australia.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 pla

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.


Locations(1)

The Royal Adelaide Hospital - Adelaide

SA, Australia

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ACTRN12621000208808


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