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

Primary Purpose

Atrial Fibrillation

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Sodium Glucose Co-transporter 2 (SGLT2) Inhibitor
Rhythm control and anticoagulation
Sponsored by
Aswan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atrial Fibrillation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Dapagliflozin

    Placebo

    Arm Description

    patients who will receive SGLT2 inhibitors

    Patients who will receive Rhythm control +/- oral anticoagulation

    Outcomes

    Primary Outcome Measures

    Left atrial remodeling
    by measuring Indexed LA volume (LAVI) in ml/m2
    Changes in left atrial strain
    by measuring left atrial strain %
    Changes in left atrial systolic force
    by measuring left atrial systolic force in ml/m3

    Secondary Outcome Measures

    Mean percentage of time spent in atrial fibrillation
    By documented ECG or Holter monitoring
    Mortality Rate
    all cause mortality
    Incidence of Hospitalization due to HF
    In hospital admission by HF symptoms
    Number of participants with Stroke
    Ischemic or hemorrhagic

    Full Information

    First Posted
    July 25, 2023
    Last Updated
    August 14, 2023
    Sponsor
    Aswan University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05993897
    Brief Title
    Effect of Sodium Glucose Co-transporter 2 Inhibitors on Left Atrial Remodeling
    Official Title
    Effect of Sodium Glucose Co-transporter 2 Inhibitors on Left Atrium Remodeling in Non-valvular Paroxysmal Atrial Fibrillation Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 2023 (Anticipated)
    Primary Completion Date
    August 2024 (Anticipated)
    Study Completion Date
    December 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Aswan University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Atrial Fibrillation

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Dapagliflozin
    Arm Type
    Active Comparator
    Arm Description
    patients who will receive SGLT2 inhibitors
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Patients who will receive Rhythm control +/- oral anticoagulation
    Intervention Type
    Drug
    Intervention Name(s)
    Sodium Glucose Co-transporter 2 (SGLT2) Inhibitor
    Intervention Description
    10 mg of Dapagliflozin orally once daily
    Intervention Type
    Drug
    Intervention Name(s)
    Rhythm control and anticoagulation
    Intervention Description
    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 Outcome Measure Information:
    Title
    Left atrial remodeling
    Description
    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
    Title
    Changes in left atrial strain
    Description
    by measuring left atrial strain %
    Time Frame
    Before first administration of treatment and will be repeated 6 months after while still on treatment
    Title
    Changes in left atrial systolic force
    Description
    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 Outcome Measure Information:
    Title
    Mean percentage of time spent in atrial fibrillation
    Description
    By documented ECG or Holter monitoring
    Time Frame
    After the first dose of treatment till the end of the study (1 year)
    Title
    Mortality Rate
    Description
    all cause mortality
    Time Frame
    After the first dose of treatment till the end of the study (1 year)
    Title
    Incidence of Hospitalization due to HF
    Description
    In hospital admission by HF symptoms
    Time Frame
    After the first dose of treatment till the end of the study (1 year)
    Title
    Number of participants with Stroke
    Description
    Ischemic or hemorrhagic
    Time Frame
    After the first dose of treatment till the end of the study (1 year)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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