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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04583813
Other study ID # MGH_001
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date September 2021
Est. completion date April 2024

Study information

Verified date April 2021
Source Miulli General Hospital
Contact Antonio Di Monaco, MD
Phone +390803054357
Email a.dimonaco@miulli.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 400
Est. completion date April 2024
Est. primary completion date January 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Intervention

Drug:
Empagliflozin
Empagliflozin 10 mg oral tablet, once daily, for 24 months
Other:
Placebo
Empagliflozin matching placebo, once daily, for 24 months

Locations

Country Name City State
Italy Miulli General Hospital Acquaviva Delle Fonti Bari

Sponsors (1)

Lead Sponsor Collaborator
Miulli General Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Other 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
Other Changes in measure of the adverse effects of heart failure on patient's life 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
Other 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
Other 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
Primary 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
Secondary 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
Secondary Hospitalizations for cardiovascular events To compare the incidence at the end of study period of hospitalizations for cardiovascular events Baseline through 24-months
Secondary Safety endpoint: Incidence of adverse events To estimate the incidence of adverse events Baseline through 24-months
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