| Registry | NCT04780438 |
|---|---|
| Status | Unknown |
| Phase | Early Phase 1 |
| Study type | Interventional; randomized, parallel, masking: single, prevention |
| Enrollment | 350 (Estimated) |
| Sponsor | G.Gennimatas General Hospital (Other); collaborators: Attikon Hospital |
| Conditions | Atrial Fibrillation Recurrent, Pulmonary Venous Isolation, Catheter Ablation, Sodium-glucose Co-transporter 2 Inhibitors |
| Interventions | Dapagliflozin, Placebo (Drug) |
| Dates | start 2021-09-01 (estimated), primary completion 2023-09-01 (estimated), completion 2023-12-01 (estimated), first posted 2021-03-03, last updated 2021-07-27 |
| Locations | 2 sites in Greece |
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All trials for Atrial Fibrillation Recurrent All trials for Pulmonary Venous Isolation All trials of Dapagliflozin All trials of Placebo
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Dapagliflozin | Active comparator | Drug: Dapagliflozin | Patients who will be randomized to receive dapagliflozin following catheter ablation. |
| Placebo | Placebo comparator | Drug: Placebo | Patients who will be randomized to receive placebo following catheter ablation. |
Sex: All, ages: 18 Years to 100 Years
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Cardiology Department, Athens General Hospital "G. Gennimatas", Athens, Greece | Athens | Greece | |
| 2nd Department of Cardiology, National and Kapodistrian University of Athens, Faculty of Medicine, Athens, Greece. | Athens | Greece |