Atrial Fibrillation
Conditions
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.
Interventions
10 mg of Dapagliflozin orally once daily
DRUGRhythm control and anticoagulation
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.
Sponsors
Aswan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 strain | Before first administration of treatment and will be repeated 6 months after while still on treatment | by measuring left atrial strain % |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| Number of participants with Stroke | After the first dose of treatment till the end of the study (1 year) | Ischemic or hemorrhagic |
Countries
Egypt
Outcome results
None listed