NCT05029115Enrolling by invitation
The Effect of SGLT-2 Inhibitor in Patient With Atrial Fibrillation and Diabetes Mellitus
Source: ClinicalTrials.gov · Last updated 23 Jan 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 716 (estimated)
- First submitted
- 22 Aug 2021
- Start date
- 5 Oct 2021
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Ewha Womans University Mokdong Hospital
- Diseases
- Atrial fibrillation, Type 2 diabetes
- NCT number
- NCT05029115
What you commit to
- Study type: Observational
- Planned participants: 716
- From 5 Oct 2021 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Lab values
- HbA1c ≥12% or HbA1c \<6.5% at diagnosis
- Renal dysfunction (eGFR-CKD-EPI \<30ml/min/1.73m\^2)
Age
- Under 20 years old or over 80 years old
Other
- 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
Who the study is looking for
- 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.
Age in the registry: 20 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ewha womans university mokdong hospital Coordinator of this site? Confirm its status | Yangcheon | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.