The Effect of SGLT-2 Inhibitor in Patient With Atrial Fibrillation and Diabetes Mellitus

January 19, 2023 updated by: Ewha Womans University Mokdong Hospital
This study was designed to compare the effects on atrial rhythm control between SGLT2 inhibitor and other oral hypoglycemic agents in patients with atrial fibrillation and diabetes mellitus. We are to compare efficacy and safety between these two groups.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study is a multicenter, prospective open blinded-endpoint design, 1:1 randomized, and controlled study, with total of 716 patients enrolled from 4-5 centers. The primary outcome is recurrence rate of atrial fibrillation within a year, when recurrence of atrial fibrillation is defined as at least one significant atrial fibrillation documented on 24-hour Holter ECG. Secondary outcomes are atrial fibrillation free survival, atrial fibrillation burden at various time points, ablation rate within a year, atrial fibrillation recurrence rate after ablation within a year, volume of left atrium, NT-ProBNP, Symptom score and Quality of Life.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
716

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Seoul
      • Yangcheon, Seoul, Korea, Republic of, 07985
        • Ewha womans university Mokdong Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The patients who diagnosed AF and T2DM in one year

Description

Inclusion Criteria:

  • At least one episode of atrial fibrillation* that is documented during the prior year by any kind of ECG recording.
  • Diabetes mellitus type II was diagnosed. (HBA1c >6.5%) and are using oral hypoglycemic agents only
  • At least 20 years old and not older than 80 years old.
  • Normal ECG parameters when measured in sinus rhythm (QRS width ≤120 ms, QTc interval <440 ms, and PQ interval ≤210 ms in a 12 lead ECG)
  • Able and willing to give informed consent.

Exclusion Criteria:

  • Any disease that limits life expectancy under 1 year
  • Subject for another clinical trial within the past 2 months
  • Under 20 years old or over 80 years old
  • Pregnant women
  • Lactating women
  • Drug abuser
  • Type 2 DM treated by recombinant insulin
  • Diagnosis of Type 1 DM, MODY, or secondary DM
  • HbA1c ≥12% or HbA1c <6.5% at diagnosis
  • Previous treatment with any SGLT2 inhibitor
  • Renal dysfunction (eGFR-CKD-EPI <30ml/min/1.73m^2)
  • Chronic cystitis and/or recurrent genitourinary tract infections (3 or more in the last year)
  • Unexplained hematuria at baseline study
  • Systolic BP >180mmHg or diastolic BP >100mmHg at baseline study
  • Systolic BP <95mmHg at baseline study
  • Previous treatment with AF ablation
  • Acute cardiovascular event [e.g., stroke, acute coronary syndrome (ACS), revascularization, decompensated HF, sustained ventricular tachycardia, return of spontaneous circulation (ROSC)] <8 weeks prior to baseline study
  • Severe valvular disease or have prosthetic valve
  • Treatment with chronic oral steroid (>30 consecutive days) at a dose equivalent to oral prednisolone ≥10mg/d, within the past 1 month
  • History of any malignancy within 5 years
  • Clinically profound hepatic dysfunction
  • Clinically uncontrolled thyroid dysfunction
  • Patients incapable of completing the trial due to any severe medical condition by clinical decision
  • Patients with poor compliance (defined as 80 - 120%), except for reasonable situations judged by physician

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
SGLT-2 inhibitor administration group
The group who administrated SGLT-2 inhibitor for hypoglycemic medication
Drug: SGLT2 inhibitor
Dapagliflozin, Empagliflozin
control
The group who are not administrated SGLT-2 inhibitor

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
recurrence rate of AF within a year in all participants
Time Frame: during 1 year
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
Time Frame: 1 year
Recurrence rates of AF after stepwise rhythm control therapies including anti-arrhythmic drugs (AAD) and ablation.
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Atrial fibrillation free survival
Time Frame: from enrollment to recurrence
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
Time Frame: at the enrollment and 3, 6, 9 and 12 months after enrollment
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
Time Frame: 1 year
percentage of patients undergone ablation within a year
1 year
Sinus rhythm maintenance rate
Time Frame: at the enrollment and 3, 6, 9 and 12 months after enrollment
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
Time Frame: difference between the time of enrollment and the time after 1 year
mm, measuring by transthoracic echocardiography
difference between the time of enrollment and the time after 1 year
NT-proBNP
Time Frame: difference between the time of enrollment and the time after 1 year
pg/mL
difference between the time of enrollment and the time after 1 year
mEHRA (modified European Heart Rhythm Association) symptom score
Time Frame: at the enrollment and 3, 6, 9 and 12 months after enrollment
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
Time Frame: at the enrollment and after 1 year
consisted of 20 questions. Lower AFEQT score means high AF severity.
at the enrollment and after 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ewha Womans University Mokdong Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 5, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2025

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 22, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 31, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 23, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BEYOND trial

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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