Clinical trial
Effect of Sodium Glucose Co-transporter 2 Inhibitors on Left Atrium Remodeling in Non-valvular Paroxysmal Atrial Fibrillation Patients
Name
693/11/22
Description
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.
Trial arms
Trial start
2023-08-01
Estimated PCD
2024-08-01
Trial end
2024-12-01
Status
Not yet recruiting
Treatment
Sodium Glucose Co-transporter 2 (SGLT2) Inhibitor
10 mg of Dapagliflozin orally once daily
Arms:
Dapagliflozin
Rhythm 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.
Arms:
Dapagliflozin, Placebo
Size
60
Primary endpoint
Left atrial remodeling
Before first administration of treatment and will be repeated 6 months after while still on treatment
Changes in 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
Before first administration of treatment and will be repeated 6 months after while still on treatment
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}
Updated at
2023-08-15
1 organization
2 products
1 indication
Organization
Aswan UniversityIndication
Atrial Fibrillation