Back to resultsEmpagliflozin and Atrial Fibrillation Treatment (EMPA-AF)
Primary Purpose
Atrial Fibrillation, Heart Failure, Obesity
Status
Not yet recruiting
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Empagliflozin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation
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
- Myocardial infarction within 60 days prior to enrolment
- Contraindications to oral anticoagulation
- Active systemic infection or sepsis
- Left atrial thrombus (e.g., transesophageal echocardiography, computed tomography and intracardiac echocardiography)
- History of a documented thromboembolic event such as stroke or transient ischemic neurological attack in the three months prior to enrollment
- Currently enrolled in another trial that has not completed the required follow-up period and would conflict with this study
- Chronic liver diseases
- Chronic kidney disease (creatinine clearance < 45 ml/min)
- Pregnant or breast-feeding mothers
- Any other clinical condition that might jeopardize patient safety during participation in this trial or prevent the subject from adhering to the trial protocol
Sites / Locations
- Miulli General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Empagliflozin
Placebo
Arm Description
Empagliflozin 10 mg oral tablet, once daily, for 24 months
Empagliflozin matching placebo oral tablet, once daily for 24 months
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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)
Hospitalizations for cardiovascular events
To compare the incidence at the end of study period of hospitalizations for cardiovascular events
Safety endpoint: Incidence of adverse events
To estimate the incidence of adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04583813
Brief Title
Empagliflozin and Atrial Fibrillation Treatment
Acronym
EMPA-AF
Official Title
Efficacy of Empagliflozin in Patients With Heart Failure and Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2021 (Anticipated)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Miulli General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Heart Failure, Obesity, Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Empagliflozin
Arm Type
Active Comparator
Arm Description
Empagliflozin 10 mg oral tablet, once daily, for 24 months
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Empagliflozin matching placebo oral tablet, once daily for 24 months
Intervention Type
Drug
Intervention Name(s)
Empagliflozin
Other Intervention Name(s)
Empagliflozin 10 mg oral tablet
Intervention Description
Empagliflozin 10 mg oral tablet, once daily, for 24 months
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo oral tablet
Intervention Description
Empagliflozin matching placebo, once daily, for 24 months
Primary Outcome Measure Information:
Title
Maintenance of sinus rhythm after the blanking period
Description
To compare the proportion of patients with sinus rhythm from 90 days after baseline to end of study period
Time Frame
From 90 days after baseline to 24-months
Secondary Outcome Measure Information:
Title
Composite of major adverse cardiovascular events
Description
To compare the incidence at the end of study period of major adverse cardiovascular events (death, non-fatal myocardial infarction, acute cerebrovascular events)
Time Frame
Baseline through 24-months
Title
Hospitalizations for cardiovascular events
Description
To compare the incidence at the end of study period of hospitalizations for cardiovascular events
Time Frame
Baseline through 24-months
Title
Safety endpoint: Incidence of adverse events
Description
To estimate the incidence of adverse events
Time Frame
Baseline through 24-months
Other Pre-specified Outcome Measures:
Title
Economic burden of hospitalizations for cardiovascular events
Description
To compare economic burden of hospitalizations for cardiovascular events estimated as the hospital reimbursement from National Health Service for cardiovascular admissions during study period
Time Frame
Baseline through 24-months
Title
Changes in measure of the adverse effects of heart failure on patient's life
Description
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.
Time Frame
Baseline, 1, 3, 6, 12 and 24 month
Title
Changes in patient's perception of health status
Description
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.
Time Frame
Baseline, 1, 3, 6, 12 and 24 month
Title
Changes in patient's functional capacity
Description
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.
Time Frame
Baseline, 1, 3, 6, 12 and 24 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Myocardial infarction within 60 days prior to enrolment
Contraindications to oral anticoagulation
Active systemic infection or sepsis
Left atrial thrombus (e.g., transesophageal echocardiography, computed tomography and intracardiac echocardiography)
History of a documented thromboembolic event such as stroke or transient ischemic neurological attack in the three months prior to enrollment
Currently enrolled in another trial that has not completed the required follow-up period and would conflict with this study
Chronic liver diseases
Chronic kidney disease (creatinine clearance < 45 ml/min)
Pregnant or breast-feeding mothers
Any other clinical condition that might jeopardize patient safety during participation in this trial or prevent the subject from adhering to the trial protocol
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antonio Di Monaco, MD
Phone
+390803054357
Email
a.dimonaco@miulli.it
Facility Information:
Facility Name
Miulli General Hospital
City
Acquaviva Delle Fonti
State/Province
Bari
ZIP/Postal Code
70021
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio Di Monaco, MD
Phone
+390803054357
Email
a.dimonaco@miulli.it
First Name & Middle Initial & Last Name & Degree
Massimo Grimaldi, MD
First Name & Middle Initial & Last Name & Degree
Antonio Di Monaco, MD
12. IPD Sharing Statement
Learn more about this trial
Empagliflozin and Atrial Fibrillation Treatment
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