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

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ClinicalTrials.gov Identifier: NCT04780438
Recruitment Status : Not yet recruiting
First Posted : March 3, 2021
Last Update Posted : March 17, 2021
Sponsor:
Collaborator:
2nd Department of Cardiology, "Attikon" University Hospital, National and Kapodistrian University of Athens
Information provided by (Responsible Party):
Ioannis Anagnostopoulos, G.Gennimatas General Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Atrial Fibrillation Recurrent Pulmonary Venous Isolation Catheter Ablation Sodium-glucose Co-transporter 2 Inhibitors Drug: Dapagliflozin Drug: Placebo Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Dapagliflozin to Prevent Atrial Fibrillation Recurrence After Transcatheter Pulmonary Venous Isolation.
Estimated Study Start Date : April 1, 2021
Estimated Primary Completion Date : September 1, 2023
Estimated Study Completion Date : December 1, 2023

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.

  2. 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.

  3. Incidence (cases per 100 patient-years)of lower urinary tract infections [ Time Frame: 18 months from the PVI procedure ]
  4. Comparison of all cause mortality between the two groups [ Time Frame: 18 months from the PVI procedure ]


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04780438


Contacts
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Contact: Spyridon Deftereos, Prof. spdeftereos@gmail.com
Contact: Georgios Giannopoulos, Prof. +302107768132 spdeftereos@gmail.comgeorgios.giannopolous@yale.edu

Locations
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Greece
Cardiology Department, Athens General Hospital "G. Gennimatas", Athens, Greece
Athens, Greece, 11527
Contact: Ioannis Anagnostopoulos, MD    +302107768132    iannis.anagnostopoulos@gmail.com   
2nd Department of Cardiology, National and Kapodistrian University of Athens, Faculty of Medicine, Athens, Greece.
Athens, Greece, 12462
Contact: Dimitrios Vrachatis, MD,PhD       dvrachatis@gmail.com   
Sponsors and Collaborators
G.Gennimatas General Hospital
2nd Department of Cardiology, "Attikon" University Hospital, National and Kapodistrian University of Athens
Investigators
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Principal Investigator: Spyridon Deftereos, MD 2nd Department of Cardiology, National and Kapodistrian University of Athens, Faculty of Medicine, Athens, Greece
Publications of Results:

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Responsible Party: Ioannis Anagnostopoulos, MD, G.Gennimatas General Hospital
ClinicalTrials.gov Identifier: NCT04780438    
Other Study ID Numbers: 2662
First Posted: March 3, 2021    Key Record Dates
Last Update Posted: March 17, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Ioannis Anagnostopoulos, G.Gennimatas General Hospital:
dapagliflozin
Sodium-glucose co-transporter 2 inhibitors
Atrial Fibrillation
recurrence
catheter ablation
SGLT2 inhibitors
Additional relevant MeSH terms:
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Atrial Fibrillation
Recurrence
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Disease Attributes
2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs