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

Not Applicable

Not yet recruiting

• Conditions: Atrial Fibrillation
• Interventions: Drug: Sodium Glucose Co-transporter 2 (SGLT2) Inhibitor; Drug: Rhythm control and anticoagulation

• Registration Number: NCT05993897
• Lead Sponsor: Aswan University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-25
• Status Verified: 2023-08
• Study Start: 2023-08
• Study First Submitted QC: 2023-08-14
• Last Update Submitted: 2023-08-14
• Study First Posted: 2023-08-15
• Last Update Posted: 2023-08-15
• Primary Completion: 2024-08
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dapagliflozin	Rhythm control and anticoagulation	patients who will receive SGLT2 inhibitors
Dapagliflozin	Sodium Glucose Co-transporter 2 (SGLT2) Inhibitor	patients who will receive SGLT2 inhibitors
Placebo	Rhythm control and anticoagulation	Patients who will receive Rhythm control +/- oral anticoagulation

Primary Outcome Measures

Name	Time	Method
Changes in left atrial strain	Before first administration of treatment and will be repeated 6 months after while still on treatment	by measuring left atrial strain %
Left atrial remodeling	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	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 Outcome Measures

Name	Time	Method
Mortality Rate	After the first dose of treatment till the end of the study (1 year)	all cause mortality
Incidence of Hospitalization due to HF	After the first dose of treatment till the end of the study (1 year)	In hospital admission by HF symptoms
Mean percentage of time spent in atrial fibrillation	After the first dose of treatment till the end of the study (1 year)	By documented ECG or Holter monitoring
Number of participants with Stroke	After the first dose of treatment till the end of the study (1 year)	Ischemic or hemorrhagic