SGLT-2 InhibitorNCT05029115
The Effect of SGLT-2 Inhibitor in Patient With Atrial Fibrillation and Diabetes Mellitus
An observational study of SGLT-2 Inhibitor and Atrial Fibrillation, run by Ewha Womans University Mokdong Hospital at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- SGLT-2 Inhibitor, Atrial Fibrillation, Diabetes Mellitus, Type 2
- What is being tested?
- SGLT2 inhibitor
- How many people
- 716 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Oct 2021to Dec 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients who diagnosed AF and T2DM in one year
Who may be able to join
- 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.
Who cannot join
- 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
Show all 24Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Ewha womans university mokdong hospital
Yangcheon, Seoul, 07985
About this study
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.
Read the 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.
- Being tested
- SGLT2 inhibitor
- Medical subject headings
- Atrial Fibrillation, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGLT2 inhibitorDrug
Dapagliflozin, Empagliflozin
| Study group | Role | What they receive |
|---|---|---|
| SGLT-2 inhibitor administration group | The group who administrated SGLT-2 inhibitor for hypoglycemic medication Receives: Drug: SGLT2 inhibitor | |
| control | The group who are not administrated SGLT-2 inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 year
Secondary outcomes (8)
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
Measured: from enrollment to recurrence
Atrial fibrillation burden
AF burden is defined as atrial fibrillation time percentage documented on 24-hour Holter ECG
Measured: at the enrollment and 3, 6, 9 and 12 months after enrollment
Ablation rate
percentage of patients undergone ablation within a year
Measured: 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
Measured: at the enrollment and 3, 6, 9 and 12 months after enrollment
Diameter of left atrium
mm, measuring by transthoracic echocardiography
Measured: difference between the time of enrollment and the time after 1 year
NT-proBNP
pg/mL
Measured: 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.
Measured: 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.
Measured: at the enrollment and after 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2021
- Study start5 Oct 2021
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SGLT-2 InhibitorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 716 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Ewha Womans University Mokdong Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sumi Jung, Study director, Ewha Womans University Mokdong Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05029115
- Sponsor's protocol ID
- BEYOND trial
- Status last verified
- Jan 2023
- First submitted
- 22 Aug 2021
- Last updated
- 23 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lee K, Lee SK, Lee J, Jeon BK, Kim TH, Yu HT, Lee JM, Park JK, Baek YS, Kim DH, Shim J, Joung B, Lee MH, Pak HN, Park J. Protocol of BEYOND trial: Clinical BEnefit of sodium-glucose cotransporter-2 (SGLT-2) inhibitors in rhYthm cONtrol of atrial fibrillation in patients with diabetes mellitus. PLoS One. 2023 Jan 18;18(1):e0280359. doi: 10.1371/journal.pone.0280359. eCollection 2023.
PubMed 36652465
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of SGLT-2 Inhibitor in Patient With Atrial Fibrillation and Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05029115
- Acronym / sponsor ID
- BEYOND trial
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 716 participants (estimated)
- Lead sponsor
- Ewha Womans University Mokdong HospitalUniversity, hospital or other
- Study start
- 5 Oct 2021 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 31 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SGLT-2 inhibitor administration group | – | Drug: SGLT2 inhibitorThe group who administrated SGLT-2 inhibitor for hypoglycemic medication |
| control | – | –The group who are not administrated SGLT-2 inhibitor |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients who diagnosed AF and T2DM in one year
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SGLT2 inhibitorDapagliflozin, Empagliflozin | Drug | SGLT-2 inhibitor administration group |
Primary outcome
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.
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.
8 secondary outcomes
Atrial fibrillation free survival
Time frame: from enrollment to recurrence
Atrial fibrillation burden
Time frame: at the enrollment and 3, 6, 9 and 12 months after enrollment
Ablation rate
Time frame: 1 year
Sinus rhythm maintenance rate
Time frame: 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
NT-proBNP
Time frame: 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
Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) score
Time frame: at the enrollment and after 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2023.
- Derived from this study: PubMed 36652465Lee K, Lee SK, Lee J, Jeon BK, Kim TH, Yu HT, Lee JM, Park JK, Baek YS, Kim DH, Shim J, Joung B, Lee MH, Pak HN, Park J. Protocol of BEYOND trial: Clinical BEnefit of sodium-glucose cotransporter-2 (SGLT-2) inhibitors in rhYthm cONtrol of atrial fibrillation in patients with diabetes mellitus. PLoS One. 2023 Jan 18;18(1):e0280359. doi: 10.1371/journal.pone.0280359. eCollection 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sumi Jung study director
Ewha Womans University Mokdong Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SGLT-2 Inhibitor and Atrial Fibrillation, run by Ewha Womans University Mokdong Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 23 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrence rate of AF within a year in all participants (time frame: during 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05029115, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2023.