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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dapagliflozin | Active Comparator | patients who will receive SGLT2 inhibitors |
|
| Placebo | Placebo Comparator | Patients who will receive Rhythm control +/- oral anticoagulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium Glucose Co-transporter 2 (SGLT2) Inhibitor | Drug | 10 mg of Dapagliflozin orally once daily |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| Rhythm control and anticoagulation | Drug | 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. |
|
| 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) |
| D013568 |
| Pathological Conditions, Signs and Symptoms |