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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||350 participants|
|Intervention Model:||Parallel Assignment|
|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|
Active Comparator: Dapagliflozin
Patients who will be randomized to receive dapagliflozin following catheter ablation.
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.
Patients rendomized in this arm will receive placebo.
- 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.
- 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.
- 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.
- Incidence (cases per 100 patient-years)of lower urinary tract infections [ Time Frame: 18 months from the PVI procedure ]
- Comparison of all cause mortality between the two groups [ Time Frame: 18 months from the PVI procedure ]
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
|Contact: Spyridon Deftereos, Prof.||email@example.com|
|Contact: Georgios Giannopoulos, Prof.||+firstname.lastname@example.org@yale.edu|
|Cardiology Department, Athens General Hospital "G. Gennimatas", Athens, Greece|
|Athens, Greece, 11527|
|Contact: Ioannis Anagnostopoulos, MD +302107768132 email@example.com|
|2nd Department of Cardiology, National and Kapodistrian University of Athens, Faculty of Medicine, Athens, Greece.|
|Athens, Greece, 12462|
|Contact: Dimitrios Vrachatis, MD,PhD firstname.lastname@example.org|
|Principal Investigator:||Spyridon Deftereos, MD||2nd Department of Cardiology, National and Kapodistrian University of Athens, Faculty of Medicine, Athens, Greece|