Effect of Sodium Glucose Co-transporter 2 Inhibitors on Left Atrial Remodeling

Aswan University

Status: Not yet enrolling

Conditions: Atrial Fibrillation

Treatments: Drug: Rhythm control and anticoagulation; Drug: Sodium Glucose Co-transporter 2 (SGLT2) Inhibitor

Study type: Interventional

Funder types: Other

Identifiers

NCT05993897

693/11/22

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. with non-valvular paroxysmal atrial fibrillation (AF that terminates spontaneously or with intervention within seven days of onset).
2. Patient age 18-60 years.
3. Patients with Glomerular Filtration Rate (GFR) >45 ml/min/1.73m2 (Cockcroft-Gault equation).
4. Patient with normal left atrium or dilated (diameter <5 cm)

Exclusion criteria

1. Patients < 18 yrs old.
2. Patients with valvular heart diseases (Moderate to severe MS, severe AS, Prosthetic heart valves).
3. Patients with left atrium > 5cm.
4. Patients with glomerular Filtration Rate (GFR) <45 ml/min/1.73m2 (Cockcroft-Gault equation).
5. Patient with ischemic heart disease (previous MI, UA, PCI or CABG).
6. Patient with previous ischemic stroke.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups, including a placebo group

Dapagliflozin

Active Comparator group

Description:

patients who will receive SGLT2 inhibitors

Treatment:

Drug: Rhythm control and anticoagulation

Drug: Sodium Glucose Co-transporter 2 (SGLT2) Inhibitor

Placebo

Placebo Comparator group

Description:

Patients who will receive Rhythm control +/- oral anticoagulation

Treatment:

Drug: Rhythm control and anticoagulation