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Clinical Trial Details

Trial ID: L5594
Source ID: NCT05029115
Associated Drug: Sglt2 Inhibitor
Title: The Effect of SGLT-2 Inhibitor in Patient With Atrial Fibrillation and Diabetes Mellitus
Acronym:
Status: ENROLLING_BY_INVITATION
Study Results: NO
Results:
Conditions: SGLT-2 Inhibitor|Atrial Fibrillation|Diabetes Mellitus, Type 2
Interventions: DRUG: SGLT2 inhibitor
Outcome Measures: Primary: recurrence rate of AF within a year in all participants, Recurrence rates of AF after stepwise rhythm control therapies including anti-arrhythmic drugs (AAD) and ablation., during 1 year|recurrence rate of AF within a year in ablated participants, Recurrence rates of AF after stepwise rhythm control therapies including anti-arrhythmic drugs (AAD) and ablation., 1 year | Secondary: Atrial fibrillation free survival, will be compared between two groups as the first of the secondary outcome, analyzed with Kaplan-Meier method and documented on curve, from enrollment to recurrence|Atrial fibrillation burden, AF burden is defined as atrial fibrillation time percentage documented on 24-hour Holter ECG, at the enrollment and 3, 6, 9 and 12 months after enrollment|Ablation rate, percentage of patients undergone ablation within a year, 1 year|Sinus rhythm maintenance rate, Sinus rhythm is considered stable when either a standard ECG or a 24-hour Holter ECG showed no episode of clinically relevant arrhythmia, including AF, at the time of check-up, at the enrollment and 3, 6, 9 and 12 months after enrollment|Diameter of left atrium, mm, measuring by transthoracic echocardiography, difference between the time of enrollment and the time after 1 year|NT-proBNP, pg/mL, difference between the time of enrollment and the time after 1 year|mEHRA (modified European Heart Rhythm Association) symptom score, 1, 2a, 2b, 3 and 4. High score means high AF severity., at the enrollment and 3, 6, 9 and 12 months after enrollment|Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) score, consisted of 20 questions. Lower AFEQT score means high AF severity., at the enrollment and after 1 year
Sponsor/Collaborators: Sponsor: Ewha Womans University Mokdong Hospital
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 716
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2021-10-05
Completion Date: 2026-12
Results First Posted:
Last Update Posted: 2023-01-23
Locations: Ewha womans university mokdong hospital, Yangcheon, Seoul, 07985, Korea, Republic of
URL: https://clinicaltrials.gov/show/NCT05029115