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

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Sodium Glucose Co-transporter 2 Inhibitors on Left Atrium Remodeling in Non-valvular Paroxysmal Atrial Fibrillation Patients

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Drug: Sodium Glucose Co-transporter 2 (SGLT2) Inhibitor
* Drug: Rhythm control and anticoagulation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dapagliflozin<br>patients who will receive SGLT2 inhibitors | Drug: Sodium Glucose Co-transporter 2 (SGLT2) Inhibitor<br>* 10 mg of Dapagliflozin orally once daily<br>Drug: Rhythm control and anticoagulation<br>* In acute stage: Cardioversion with D.C shock if haemodynamically unstable, after failure of pharmacological cardioversion or participant preference. or pharmacological cardioversion with either IV cordarone in structurally abnormal heart (150mg over 10 minutes followed by1 mg/min infusion for 6 hours followed by 0.5 mg/min not exceeding 2.4 grams over 24 hours till restoration of sinus Rhythm. Then maintenance dose of 200 mg tab orally every 8 hours for 3 weeks then 200 mg tab orally once per day. or Propafenone (Rytmonorm) 600 mg single oral dose in structurally normal heart then maintenance dose of 150mg tab orally every 8 hours. + Rivaroxaban 20mg orally once daily if CHA2DS2 VASc score 1 or more for males and 2 or more for females.<br>|
| Placebo Comparator: Placebo<br>Patients who will receive Rhythm control +/- oral anticoagulation | Drug: Rhythm control and anticoagulation<br>* In acute stage: Cardioversion with D.C shock if haemodynamically unstable, after failure of pharmacological cardioversion or participant preference. or pharmacological cardioversion with either IV cordarone in structurally abnormal heart (150mg over 10 minutes followed by1 mg/min infusion for 6 hours followed by 0.5 mg/min not exceeding 2.4 grams over 24 hours till restoration of sinus Rhythm. Then maintenance dose of 200 mg tab orally every 8 hours for 3 weeks then 200 mg tab orally once per day. or Propafenone (Rytmonorm) 600 mg single oral dose in structurally normal heart then maintenance dose of 150mg tab orally every 8 hours. + Rivaroxaban 20mg orally once daily if CHA2DS2 VASc score 1 or more for males and 2 or more for females.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left atrial remodeling | by measuring Indexed LA volume (LAVI) in ml/m2 | Before first administration of treatment and will be repeated 6 months after while still on treatment | 
| Changes in left atrial strain | by measuring left atrial strain % | Before first administration of treatment and will be repeated 6 months after while still on treatment | 
| Changes in left atrial systolic force | by measuring left atrial systolic force in ml/m3 | Before first administration of treatment and will be repeated 6 months after while still on treatment | 

Secondary Outcome Measures

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