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

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

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 Overview

• Status: Not yet recruiting
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Drug: Sodium Glucose Co-transporter 2 (SGLT2) Inhibitor; Drug: Rhythm control and anticoagulation

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dapagliflozin; patients who will receive SGLT2 inhibitors	Drug: Sodium Glucose Co-transporter 2 (SGLT2) Inhibitor; 10 mg of Dapagliflozin orally once daily; Drug: 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.
Placebo Comparator: Placebo; Patients who will receive Rhythm control +/- oral anticoagulation	Drug: 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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Aswan University

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2023
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: July 25, 2023
• First Submitted That Met QC Criteria: August 14, 2023
• First Posted (Actual): August 15, 2023

Study Record Updates

• Last Update Posted (Actual): August 15, 2023
• Last Update Submitted That Met QC Criteria: August 14, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 693/11/22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No