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

Sponsor
Aswan University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05993897
Collaborator
(none)
60
Enrollment
2
Arms
16
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Sodium Glucose Co-transporter 2 (SGLT2) Inhibitor
  • Drug: Rhythm control and anticoagulation
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Effect of Sodium Glucose Co-transporter 2 Inhibitors on Left Atrium Remodeling in Non-valvular Paroxysmal Atrial Fibrillation Patients
Anticipated Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Aug 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Left atrial remodeling [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 [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 [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 Outcome Measures

  1. Mean percentage of time spent in atrial fibrillation [After the first dose of treatment till the end of the study (1 year)]

    By documented ECG or Holter monitoring

  2. Mortality Rate [After the first dose of treatment till the end of the study (1 year)]

    all cause mortality

  3. Incidence of Hospitalization due to HF [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 [After the first dose of treatment till the end of the study (1 year)]

    Ischemic or hemorrhagic

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Aswan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Aml Soliman, Lecturer of cardiology, Aswan university, Aswan University
ClinicalTrials.gov Identifier:
NCT05993897
Other Study ID Numbers:
  • 693/11/22
First Posted:
Aug 15, 2023
Last Update Posted:
Aug 15, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Atrial Fibrillation

Study Results

No Results Posted as of Aug 15, 2023