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

Phase 2

Recruiting

• Conditions: Atrial Fibrillation; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12621000208808
• Lead Sponsor: The University of Adelaide

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-26
• Last Update Posted: 16 May 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in AF symptomatology assessed via the AF symptom severity score (AFSS) [ 3, 6, 9 and 12 months post randomisation (primary timepoint];Change in AF burden assessed via 7-day Holter monitor[ 3, 6, 9 and 12 months post randomisation (primary timepoint];Change in the AF effect on quality of life score (AFQET) [ 3, 6, 9 and 12 months post randomisation (primary timepoint]