Compares an SGLT2 inhibitor with other diabetes pills in atrial fibrillation
Compares an SGLT2 inhibitor with other diabetes pills in adults with atrial fibrillation and diabetes.
Plain-language title generated from the registry record
Registry title: The Effect of SGLT-2 Inhibitor in Patient With Atrial Fibrillation and Diabetes Mellitus
Key facts
- Where
- Yangcheon, South KoreaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 20 and 80 years old?
Source: NCT05029115, who can take part
Where in South Korea
- Ewha womans university mokdong hospitalYangcheon, South KoreaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ewha Womans University Mokdong Hospital
- Trial code
- NCT05029115
- Record updated
- 23 January 2023
- Original description
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 full original descriptionShow less
The Effect of SGLT-2 Inhibitor in Patient With Atrial Fibrillation and Diabetes Mellitus
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.
Inclusion: 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: Drug abuser; Previous treatment with any SGLT2 inhibitor; 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; Treatment with chronic oral steroid (>30 consecutive days) at a dose equivalent to oral prednisolone ≥10mg/d, within the past 1 month; Any disease that limits life expectancy under 1 year; Chronic cystitis and/or recurrent genitourinary tract infections (3 or more in the last year); Severe valvular disease or have prosthetic valve; History of any malignancy within 5 years; Patients incapable of completing the trial due to any severe medical condition by clinical decision; HbA1c ≥12% or HbA1c <6.5% at diagnosis; Renal dysfunction (eGFR-CKD-EPI <30ml/min/1.73m\^2); Under 20 years old or over 80 years old; Subject for another clinical trial within the past 2 months; Pregnant women; Lactating women; Type 2 DM treated by recombinant insulin; Diagnosis of Type 1 DM, MODY, or secondary DM; Unexplained hematuria at baseline study; Systolic BP >180mmHg or diastolic BP >100mmHg at baseline study; Systolic BP <95mmHg at baseline study; Clinically profound hepatic dysfunction; Clinically uncontrolled thyroid dysfunction; Patients with poor compliance (defined as 80 - 120%), except for reasonable situations judged by physician.