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

NCT05993897 | Unknown

• 1 other identifier: 693/11/22
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Mean percentage of time spent in atrial fibrillation

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

• Mortality Rate

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

• Incidence of Hospitalization due to HF

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

• Number of participants with Stroke

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

Study Arms (2)

Dapagliflozin

ACTIVE COMPARATOR

patients who will receive SGLT2 inhibitors

Drug: Sodium Glucose Co-transporter 2 (SGLT2) Inhibitor; Drug: Rhythm control and anticoagulation

Placebo

PLACEBO COMPARATOR

Patients who will receive Rhythm control +/- oral anticoagulation

Drug: Rhythm control and anticoagulation

Interventions

Sodium Glucose Co-transporter 2 (SGLT2) Inhibitor DRUG

10 mg of Dapagliflozin orally once daily

Dapagliflozin

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.

Dapagliflozin; Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aswan University: lead

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of cardiology, Aswan university

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: August 15, 2023
• Study Start: August 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: December 1, 2024
• Last Updated: August 15, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share