Effect of Sodium Glucose Co-transporter 2 Inhibitors on Left Atrium Remodeling in Non-valvular Paroxysmal Atrial Fibrillation Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Aswan University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Changes in left atrial strain
Study Overview
Brief Summary
Investigators are going to assess direct effect of SGLT2 inhibitors on left atrial remodeling in participants with nonvalvular paroxysmal atrial fibrillation regardless of diabetes status.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •with non-valvular paroxysmal atrial fibrillation (AF that terminates spontaneously or with intervention within seven days of onset).
- •Patient age 18-60 years.
- •Patients with Glomerular Filtration Rate (GFR) >45 ml/min/1.73m2 (Cockcroft-Gault equation).
- •Patient with normal left atrium or dilated (diameter <5 cm)
Exclusion Criteria
- •Patients < 18 yrs old.
- •Patients with valvular heart diseases (Moderate to severe MS, severe AS, Prosthetic heart valves).
- •Patients with left atrium > 5cm.
- •Patients with glomerular Filtration Rate (GFR) <45 ml/min/1.73m2 (Cockcroft-Gault equation).
- •Patient with ischemic heart disease (previous MI, UA, PCI or CABG).
- •Patient with previous ischemic stroke.
Arms & Interventions
Dapagliflozin
patients who will receive SGLT2 inhibitors
Intervention: Sodium Glucose Co-transporter 2 (SGLT2) Inhibitor (Drug)
Dapagliflozin
patients who will receive SGLT2 inhibitors
Intervention: Rhythm control and anticoagulation (Drug)
Placebo
Patients who will receive Rhythm control +/- oral anticoagulation
Intervention: Rhythm control and anticoagulation (Drug)
Outcomes
Primary Outcomes
Changes in left atrial strain
Time Frame: Before first administration of treatment and will be repeated 6 months after while still on treatment
by measuring left atrial strain %
Left atrial remodeling
Time Frame: Before first administration of treatment and will be repeated 6 months after while still on treatment
by measuring Indexed LA volume (LAVI) in ml/m2
Changes in left atrial systolic force
Time Frame: Before first administration of treatment and will be repeated 6 months after while still on treatment
by measuring left atrial systolic force in ml/m3
Secondary Outcomes
- Mortality Rate(After the first dose of treatment till the end of the study (1 year))
- Incidence of Hospitalization due to HF(After the first dose of treatment till the end of the study (1 year))
- Mean percentage of time spent in atrial fibrillation(After the first dose of treatment till the end of the study (1 year))
- Number of participants with Stroke(After the first dose of treatment till the end of the study (1 year))
Investigators
Aml Soliman
Lecturer of cardiology, Aswan university
Aswan University