Atrial Fibrillation, Diabetes Mellitus, Heart Failure, Obesity
Conditions
Brief summary
The primary purpose of this trial is to evaluate the impact of empagliflozin, as compared with placebo, in patients with diabetes mellitus or overweight, heart failure and atrial fibrillation.
Detailed description
A 24-month randomized, single-blind, placebo-controlled trial to investigate the efficacy of empagliflozin to reduce atrial fibrillation burden in patients with diabetes mellitus or overweight, heart failure and atrial fibrillation in which a rhythm control strategy is indicated.
Interventions
DRUGEmpagliflozin
Empagliflozin 10 mg oral tablet, once daily, for 24 months
OTHERPlacebo
Empagliflozin matching placebo, once daily, for 24 months
Sponsors
Miulli General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-80 years 2. Diabetes mellitus or Body Mass Index over 25 Kg/m2 3. Heart failure 4. New York Heart Association (NYHA) Functional Classification: II or III 5. Documented atrial fibrillation 6. Understands the nature of the study, treatment procedure and provides written informed consent 7. Willing to comply with specified pre-, post- and follow-up testing, evaluations and requirements 8. Expected to remain available for at least 24 months after enrollment
Exclusion criteria
1. Permanent atrial fibrillation 2. Current use or prior use of a sodium-glucose co-transporter (SGLT) 2 inhibitor or combined inhibitor of SGLT-1 and SGLT-2 (all the other antidiabetic drugs are permitted performing an accurate glycemic control) 3. Known allergy or hypersensitivity to any SGLT-2 inhibitors 4. History of ketoacidosis 5. Need or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial 6. New York Heart Association (NYHA) Functional Classification: I or IV 7. Unstable angina 8. Presence of any disease that is likely to shorten life expectancy to \< 1 year 9. Any cardiac surgery within three months prior to enrolment 10. Awaiting cardiac transplantation or other cardiac surgery within the next year 11. Myocardial infarction within 60 days prior to enrolment 12. Contraindications to oral anticoagulation 13. Active systemic infection or sepsis 14. Left atrial thrombus (e.g., transesophageal echocardiography, computed tomography and intracardiac echocardiography) 15. History of a documented thromboembolic event such as stroke or transient ischemic neurological attack in the three months prior to enrollment 16. Currently enrolled in another trial that has not completed the required follow-up period and would conflict with this study 17. Chronic liver diseases 18. Chronic kidney disease (creatinine clearance \< 45 ml/min) 19. Pregnant or breast-feeding mothers 20. Any other clinical condition that might jeopardize patient safety during participation in this trial or prevent the subject from adhering to the trial protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maintenance of sinus rhythm after the blanking period | From 90 days after baseline to 24-months | To compare the proportion of patients with sinus rhythm from 90 days after baseline to end of study period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Composite of major adverse cardiovascular events | Baseline through 24-months | To compare the incidence at the end of study period of major adverse cardiovascular events (death, non-fatal myocardial infarction, acute cerebrovascular events) |
| Hospitalizations for cardiovascular events | Baseline through 24-months | To compare the incidence at the end of study period of hospitalizations for cardiovascular events |
| Safety endpoint: Incidence of adverse events | Baseline through 24-months | To estimate the incidence of adverse events |
Other
| Measure | Time frame | Description |
|---|---|---|
| Economic burden of hospitalizations for cardiovascular events | Baseline through 24-months | To compare economic burden of hospitalizations for cardiovascular events estimated as the hospital reimbursement from National Health Service for cardiovascular admissions during study period |
| Changes in measure of the adverse effects of heart failure on patient's life | Baseline, 1, 3, 6, 12 and 24 month | To compare changes in adverse effects of heart failure on patient's life evaluated by using the Minnesota Living with Heart Failure Questionnaire. The total score range is 0 to 105, with higher scores indicating more significant impairment in health-related quality of life. A total score decrease indicates the amelioration of the quality of life. |
| Changes in patient's perception of health status | Baseline, 1, 3, 6, 12 and 24 month | To compare changes in perception of health status evaluated by using the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12). The total score range is 0 to 100, with higher scores indicating a better condition. A total score increase indicates amelioration of quality of life. |
| Changes in patient's functional capacity | Baseline, 1, 3, 6, 12 and 24 month | To compare changes in functional capacity evaluated by using the Six Minutes Walk Test. The distance covered over a time of 6 minutes measures functional capacity. An increase in the distance walked indicates improvement in the patient's condition. |
Countries
Italy
Contacts
Primary ContactAntonio Di Monaco, MD
Outcome results
None listed