Empagliflozin and Atrial Fibrillation Treatment

NCT04583813 | Unknown Phase 4 DMC

• 1 other identifier: MGH_001
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Heart Failure; Obesity; Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Composite of major adverse cardiovascular events

  Baseline through 24-months

• Hospitalizations for cardiovascular events

  Baseline through 24-months

• Safety endpoint: Incidence of adverse events

  Baseline through 24-months

Other Outcomes (4)

• Economic burden of hospitalizations for cardiovascular events

  Baseline through 24-months

• Changes in measure of the adverse effects of heart failure on patient's life

  Baseline, 1, 3, 6, 12 and 24 month

• Changes in patient's perception of health status

  Baseline, 1, 3, 6, 12 and 24 month

Study Arms (2)

Empagliflozin

ACTIVE COMPARATOR

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

Drug: Empagliflozin

Placebo

PLACEBO COMPARATOR

Empagliflozin matching placebo oral tablet, once daily for 24 months

Other: Placebo

Interventions

Empagliflozin DRUG

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

Also known as: Empagliflozin 10 mg oral tablet

Empagliflozin

Placebo OTHER

Empagliflozin matching placebo, once daily, for 24 months

Also known as: Placebo oral tablet

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Miulli General Hospital: lead

Study Sites (1)

Miulli General Hospital

Acquaviva delle Fonti, Bari, 70021, Italy

Location

MeSH Terms

Conditions

Atrial Fibrillation; Heart Failure; Obesity; Diabetes Mellitus

Interventions

empagliflozin; Tablets

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Central Study Contacts

Antonio Di Monaco, MD

CONTACT

+390803054357; a.dimonaco@miulli.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Arrhythmology and Electrophysiology Unit

Study Record Dates

• First Submitted: July 20, 2020
• First Posted: October 12, 2020
• Study Start: September 1, 2021
• Primary Completion: January 1, 2024
• Study Completion: April 1, 2024
• Last Updated: April 2, 2021

Record last verified: 2021-04

Locations

IT (1)