NCT04780438

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

Status unknown EARLY_PHASE1 Last updated 27 July 2021

What this trial tests

EARLY_PHASE1 trial testing Dapagliflozin in Atrial Fibrillation Recurrent in 350 participants. Status unknown.

Timeline

1 September 2021

Primary endpoint
1 September 2023

1 December 2023

Quick facts

Lead sponsor	G.Gennimatas General Hospital
Phase	EARLY_PHASE1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	350
Start date	1 September 2021
Primary completion	1 September 2023
Estimated completion	1 December 2023
Sites	2 locations across Greece

Drugs / interventions tested

• Dapagliflozin (DAPAGLIFLOZIN) — full drug profile →
• Placebo

Conditions studied

• Atrial Fibrillation Recurrent — all drugs for Atrial Fibrillation Recurrent →
• Pulmonary Venous Isolation — all drugs for Pulmonary Venous Isolation →
• Catheter Ablation — all drugs for Catheter Ablation →
• Sodium-glucose Co-transporter 2 Inhibitors — all drugs for Sodium-glucose Co-transporter 2 Inhibitors →

Sponsor

G.Gennimatas General Hospital

Who can join

Adults 18 to 100, any sex, with Atrial Fibrillation Recurrent or Pulmonary Venous Isolation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Recent Advances in Antiarrhythmic Drug Therapy.
   Saljic A, Heijman J, Dobrev D. · · 2023 · cited 38× · PMID 37540446 · DOI 10.1007/s40265-023-01923-3
2. Sodium-Glucose Cotransporter-2 Inhibitors-from the Treatment of Diabetes to Therapy of Chronic Heart Failure.
   Kurczyński D, Hudzik B, Jagosz M, Zabierowski J, et al · · 2022 · cited 5× · PMID 35877587 · DOI 10.3390/jcdd9070225