Dapagliflozin to Prevent Atrial Fibrillation Recurrence After Transcatheter Pulmonary Venous Isolation.

July 26, 2021 updated by: Ioannis Anagnostopoulos, G.Gennimatas General Hospital

Transcatheter left atrial antral ablation, aiming at complete electrical isolation of the pulmonary veins (PVI), has become mainstay in atrial fibrillation (AF) treatment. This approach has been proved superior to medical rhytmh control strategy in maintaining sinus rhythm. Moreover PVI has been associated with significant survival benefit in patients with heart failure and reduced left ventricular ejection fraction. Nevertheless, despite progress in the field of catheter ablation, recurrence rates remain high.

Inhibitors of type 2 sodium- glucose co-transporter (SGLT2i) is a relatively recent addition to the array of anti-diabetic agents, becoming part of everyday clinical practice. However, although SGLT2i were first used solely as antidiabetics because of their glycosuric effect, further research demonstrated that these drugs may independently reduce cardiovascular events, especially in patients with heart failure, a benefit that was consistent among diabetic and non-diabetic patients. Moreover, pleiotropic effects have been observed, including a reno-protective action.

These findings suggest that SGLT2i mechanisms of action extend beyond the obvious increase in urinary sodium and glucose excretion. Various studies propose that these drugs promote favourable metabolic changes in myocardial energetics, while they also inhibit inflamation and sympathetic activation, resulting in restriction of induced fibrosis and structural remodeling, which are key elements in atrial fibrillation generation and maintenance.

These findings suggest that the use of SGLT2i could offer antiarrhythmic benefit by reducing and/or reversing structural and electrical remodeling, leading to the assumption that use of theese drugs could reduce recurrences after transcatheter AF ablation.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

350

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Greece
      • Athens, Greece, 12462
        • 2nd Department of Cardiology, National and Kapodistrian University of Athens, Faculty of Medicine, Athens, Greece.
        • Contact:
      • Athens, Greece, 11527
        • Cardiology Department, Athens General Hospital "G. Gennimatas", Athens, Greece
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Age>18 years Atrial Fibrillation (paroxysmal or sustained); Written informed consent; Glomerular Filtration Rate (GFR) >45 ml/min/1.73m2 (Cockroft-Gault equation)

Exclusion Criteria:

Hypertrophic cardiomyopathy (Left ventricular wall thickness ≥15mm, not explained by abnormal pressure/volume conditions); Severe mitral valve stenosis (as defined in European Guidelines); Active malignancy; Participation in other intervention studies; Pregnancy or willing of pregnancy during the follow up period Guideline Class I or equivalent indication for treatment with a SGLT2 inhibitor

*Eligible patients randomized in the active comparator arm will be also included in a prospective observational registry study regarding the role of SGLT2 inhibitors in post-ablation AF recurrence.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Dapagliflozin
Patients who will be randomized to receive dapagliflozin following catheter ablation.
Drug: Dapagliflozin
Patients rendomized in this arm will receive dapagliflozin at a target dose of 10mg once daily.
PLACEBO_COMPARATOR: Placebo
Patients who will be randomized to receive placebo following catheter ablation.
Drug: Placebo
Patients rendomized in this arm will receive placebo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of survival free of AF/ atrial tachycardia (AT) recurrence between the two study arms.
Time Frame: 18 months from the PVI procedure
AF/AT are defined as any episodes of AF or atrial flutter or other re-entrant atrial tachycardia recorded either on surface ECG or on Holter monitoring and lasting for at least 30 s. All episodes will be reviewed by two independent electrophysiologists, who will be blinded as to patient identity and randomization.The first 3 months after the ablation procedure will be regarded as a blanking period.
18 months from the PVI procedure

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence (cases per 100 patient-years) of hypoglycemia in both arms
Time Frame: 18 months from the PVI procedure
Any episode of hypoglycemia defined as serum glucose 60< mg/dl associated with symptoms of hypoglycemia.
18 months from the PVI procedure
Incidence (cases per 100 patient-years)of diabetic ketoacidosis
Time Frame: 18 months from the PVI procedure
Any episode of metabolic acidosis (pH<7.3) with decreased serum bicarbonate (<18mEq/ml) and increased anion gap (>10) and increased serum glucose (>250mg/dl) and positive urine dipstick test for ketones.
18 months from the PVI procedure
Incidence (cases per 100 patient-years)of lower urinary tract infections
Time Frame: 18 months from the PVI procedure
18 months from the PVI procedure
Comparison of all cause mortality between the two groups
Time Frame: 18 months from the PVI procedure
18 months from the PVI procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

G.Gennimatas General Hospital

Collaborators

2nd Department of Cardiology, "Attikon" University Hospital, National and Kapodistrian University of Athens

Investigators

  • Principal Investigator: Spyridon Deftereos, MD, 2nd Department of Cardiology, National and Kapodistrian University of Athens, Faculty of Medicine, Athens, Greece

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

September 1, 2021

Primary Completion (ANTICIPATED)

September 1, 2023

Study Completion (ANTICIPATED)

December 1, 2023

Study Registration Dates

First Submitted

March 2, 2021

First Submitted That Met QC Criteria

March 2, 2021

First Posted (ACTUAL)

March 3, 2021

Study Record Updates

Last Update Posted (ACTUAL)

July 27, 2021

Last Update Submitted That Met QC Criteria

July 26, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2662

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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