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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Empagliflozin | Active Comparator | Empagliflozin 10 mg oral tablet, once daily, for 24 months |
|
| Placebo | Placebo Comparator | Empagliflozin matching placebo oral tablet, once daily for 24 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empagliflozin | Drug | Empagliflozin 10 mg oral tablet, once daily, for 24 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maintenance of sinus rhythm after the blanking period | To compare the proportion of patients with sinus rhythm from 90 days after baseline to end of study period | From 90 days after baseline to 24-months |
| Measure | Description | Time Frame |
|---|---|---|
| Composite of major adverse cardiovascular events | To compare the incidence at the end of study period of major adverse cardiovascular events (death, non-fatal myocardial infarction, acute cerebrovascular events) | Baseline through 24-months |
| Hospitalizations for cardiovascular events |
| Measure | Description | Time Frame |
|---|---|---|
| Economic burden of hospitalizations for cardiovascular events | To compare economic burden of hospitalizations for cardiovascular events estimated as the hospital reimbursement from National Health Service for cardiovascular admissions during study period | Baseline through 24-months |
| Changes in measure of the adverse effects of heart failure on patient's life |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antonio Di Monaco, MD | Contact | +390803054357 | a.dimonaco@miulli.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miulli General Hospital | Acquaviva delle Fonti | Bari | 70021 | Italy |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D006333 | Heart Failure |
| D009765 | Obesity |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| C570240 | empagliflozin |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| Placebo | Other | Empagliflozin matching placebo, once daily, for 24 months |
|
|
To compare the incidence at the end of study period of hospitalizations for cardiovascular events |
| Baseline through 24-months |
| Safety endpoint: Incidence of adverse events | To estimate the incidence of adverse events | Baseline through 24-months |
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. |
| Baseline, 1, 3, 6, 12 and 24 month |
| Changes in patient's perception of health status | 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. | Baseline, 1, 3, 6, 12 and 24 month |
| Changes in patient's functional capacity | 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. | Baseline, 1, 3, 6, 12 and 24 month |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |