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

Aswan University60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Atrial Fibrillation

Interventions

Sodium Glucose Co-transporter 2 (SGLT2) InhibitorDRUG

10 mg of Dapagliflozin orally once daily

Rhythm control and anticoagulationDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Left atrial remodeling

by measuring Indexed LA volume (LAVI) in ml/m2

Time frame: 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 %

Time frame: 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

Time frame: Before first administration of treatment and will be repeated 6 months after while still on treatment

Secondary Outcomes

Mean percentage of time spent in atrial fibrillation

By documented ECG or Holter monitoring

Time frame: After the first dose of treatment till the end of the study (1 year)

Mortality Rate

all cause mortality

Time frame: 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

Time frame: After the first dose of treatment till the end of the study (1 year)

Number of participants with Stroke

Ischemic or hemorrhagic

Time frame: After the first dose of treatment till the end of the study (1 year)

Data from ClinicalTrials.gov

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