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NCT Number: NCT05993897

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

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aswan university

Aswān, Aswan Governorate, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • with non-valvular paroxysmal atrial fibrillation (AF that terminates spontaneously or with intervention within seven days of onset).
  • Patient age 18-60 years.
  • Patients with Glomerular Filtration Rate (GFR) >45 ml/min/1.73m2 (Cockcroft-Gault equation).
  • Patient with normal left atrium or dilated (diameter <5 cm)

Exclusion criteria

  • Patients < 18 yrs old.
  • Patients with valvular heart diseases (Moderate to severe MS, severe AS, Prosthetic heart valves).
  • Patients with left atrium > 5cm.
  • Patients with glomerular Filtration Rate (GFR) <45 ml/min/1.73m2 (Cockcroft-Gault equation).
  • Patient with ischemic heart disease (previous MI, UA, PCI or CABG).
  • Patient with previous ischemic stroke.

Treatment and study plan

Sodium Glucose Co-transporter 2 (SGLT2) Inhibitor

Drug

10 mg of Dapagliflozin orally once daily

Rhythm control and anticoagulation

Drug

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.

Primary outcomes

  1. Left atrial remodeling

    Time frame: 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

  2. Changes in left atrial strain

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

    by measuring left atrial strain %

  3. Changes in left atrial systolic force

    Time frame: 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 outcomes

  1. Mean percentage of time spent in atrial fibrillation

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

    By documented ECG or Holter monitoring

  2. Mortality Rate

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

    all cause mortality

  3. Incidence of Hospitalization due to HF

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

    In hospital admission by HF symptoms

  4. Number of participants with Stroke

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

    Ischemic or hemorrhagic

Sponsors and collaborators

Lead sponsor

Aswan University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 15, 2023
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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