Empagliflozin and Atrial Fibrillation Treatment

NCT ID: NCT04583813

Last Updated: 2021-04-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-30
• Study Completion Date: 2024-04-30

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.

Conditions

Atrial Fibrillation; Heart Failure; Obesity; Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Empagliflozin

Empagliflozin 10 mg oral tablet, once daily, for 24 months

Group Type: ACTIVE_COMPARATOR

Empagliflozin

Intervention Type: DRUG

Empagliflozin 10 mg oral tablet, once daily, for 24 months

Placebo

Empagliflozin matching placebo oral tablet, once daily for 24 months

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Empagliflozin matching placebo, once daily, for 24 months

Interventions

Empagliflozin

Empagliflozin 10 mg oral tablet, once daily, for 24 months

Intervention Type: DRUG

Placebo

Empagliflozin matching placebo, once daily, for 24 months

Intervention Type: OTHER

Other Intervention Names

Empagliflozin 10 mg oral tablet; Placebo oral tablet

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Miulli General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Massimo Grimaldi

Head of Arrhythmology and Electrophysiology Unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Miulli General Hospital

Acquaviva delle Fonti, Bari, Italy

Countries

Italy

Central Contacts

Antonio Di Monaco, MD

Role: CONTACT

a.dimonaco@miulli.it

+390803054357

Facility Contacts

Antonio Di Monaco, MD

Role: primary

a.dimonaco@miulli.it

+390803054357

Other Identifiers

MGH_001

Identifier Type: -

Identifier Source: org_study_id