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

Sponsor
G.Gennimatas General Hospital
Study ID
NCT04780438
Phase
EARLY_PHASE1
Status
Unknown

Conditions

  • Atrial Fibrillation Recurrent
  • Catheter Ablation
  • Pulmonary Venous Isolation
  • Sodium-glucose Co-transporter 2 Inhibitors

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin — DRUG
    Patients rendomized in this arm will receive dapagliflozin at a target dose of 10mg once daily.
  • Placebo — DRUG
    Patients rendomized in this arm will receive placebo.

Study Details

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.

Key Dates

Start date
Sep 1, 2021
Status verified
Jul 2021
Primary completion
Sep 1, 2023
Completion
Dec 1, 2023

Study Design

Enrollment
350 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Dapagliflozin
    Patients who will be randomized to receive dapagliflozin following catheter ablation.
  • Placebo Comparator: Placebo
    Patients who will be randomized to receive placebo following catheter ablation.

Primary Outcome Measure

Comparison of survival free of AF/ atrial tachycardia (AT) recurrence between the two study arms. [ Time Frame: 18 months from the PVI procedure ]

Central Contacts