Efficacy of Empagliflozin in Patients With Heart Failure and Atrial Fibrillation
Overview
- Phase
- Phase 4
- Intervention
- Empagliflozin
- Conditions
- Atrial Fibrillation
- Sponsor
- Miulli General Hospital
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- Maintenance of sinus rhythm after the blanking period
- Last Updated
- 5 years ago
Overview
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.
Investigators
Massimo Grimaldi
Head of Arrhythmology and Electrophysiology Unit
Miulli General Hospital
Eligibility Criteria
Inclusion Criteria
- •Age 18-80 years
- •Diabetes mellitus or Body Mass Index over 25 Kg/m2
- •Heart failure
- •New York Heart Association (NYHA) Functional Classification: II or III
- •Documented atrial fibrillation
- •Understands the nature of the study, treatment procedure and provides written informed consent
- •Willing to comply with specified pre-, post- and follow-up testing, evaluations and requirements
- •Expected to remain available for at least 24 months after enrollment
Exclusion Criteria
- •Permanent atrial fibrillation
- •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)
- •Known allergy or hypersensitivity to any SGLT-2 inhibitors
- •History of ketoacidosis
- •Need or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial
- •New York Heart Association (NYHA) Functional Classification: I or IV
- •Unstable angina
- •Presence of any disease that is likely to shorten life expectancy to \< 1 year
- •Any cardiac surgery within three months prior to enrolment
- •Awaiting cardiac transplantation or other cardiac surgery within the next year
Arms & Interventions
Empagliflozin
Empagliflozin 10 mg oral tablet, once daily, for 24 months
Intervention: Empagliflozin
Placebo
Empagliflozin matching placebo oral tablet, once daily for 24 months
Intervention: Placebo
Outcomes
Primary Outcomes
Maintenance of sinus rhythm after the blanking period
Time Frame: 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 Outcomes
- Safety endpoint: Incidence of adverse events(Baseline through 24-months)
- Composite of major adverse cardiovascular events(Baseline through 24-months)
- Hospitalizations for cardiovascular events(Baseline through 24-months)