Empagliflozin and Atrial Fibrillation Treatment

Obesity Clinical Trial

— EMPA-AF  

Official title:

Efficacy of Empagliflozin in Patients With Heart Failure and Atrial Fibrillation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04583813
• Other study ID #: MGH_001
• Status: Not yet recruiting
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Diabetes Mellitus
• Heart Failure
• Obesity

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