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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05993897
• Other study ID #: 693/11/22
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2023
• Est. completion date: December 2024

Study information

• Verified date: August 2023
• Source: Aswan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Sodium Glucose Co-transporter 2 (SGLT2) Inhibitor
10 mg of Dapagliflozin orally once daily
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Aswan University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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)
Secondary	Mortality Rate	all cause mortality	After the first dose of treatment till the end of the study (1 year)
Secondary	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)
Secondary	Number of participants with Stroke	Ischemic or hemorrhagic	After the first dose of treatment till the end of the study (1 year)