Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06433479
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-05-23
Brief Title:
Efficacy of Dapagliflozin on Recurrence After Catheter Ablation for Atrial Fibrillation
Sponsor:
Beijing Anzhen Hospital
Organization:
Beijing Anzhen Hospital
Study Overview
Official Title:
Efficacy of DApagliflozin on REcurrence After Catheter Ablation for Atrial Fibrillation
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DARE-AF
Brief Summary:
This is a single-center parallel-group randomized open-label trial evaluating the effect of 3-month treatment with dapagliflozin 10mg once daily on the recurrence of atrial fibrillation after catheter ablation for atrial fibrillation in patients without diabetes heart failure or chronic kidney disease
Detailed Description:
Atrial fibrillation AF is one of the most common arrhythmias Catheter ablation of atrial fibrillation as the main means of rhythm control can effectively maintain sinus rhythm reduce the recurrence of AF burden and improve the patients quality of life and prognosis However AF recurrence still occurs in 30-50 of patients after atrial fibrillation catheter ablation and there is currently no effective strategy to reduce the recurrence rate after atrial fibrillation ablation
Sodium-glucose cotransporter 2 inhibitors SGLT2i are a new class of diabetic drugs and large clinical trials have established their multiple cardiovascular benefits Several studies demonstrated that SGLT2i might reduce AFatrial flutter events among patients with diabetes Our cohort study and meta-analysis demonstrated a lower risk of AF recurrence with the use of SGLT2i among patients with diabetes after AF ablation However the beneficial effects of SGLT2i in patients after AF catheter ablation without current indications for SGLT2i were uncertain
In this study we aim to evaluate the effect of dapagliflozin on AF burden Patients with persistent AF undergoing initial catheter ablation without diabetes at high cardiovascular risk heart failure or chronic kidney disease will be enrolled Patients will be randomly assigned to either the dapagliflozin group 10mgd for 3 months or the control group stratified according to body mass index 24 24kgm2 or left atrial diameter 4545mm
The primary outcome is atrial fibrillation burden calculated as the percentage of of all atrial arrhythmia episodes detected by 7-day single-lead ECG patches at 3 months after ablation Quality of life and echocardiography changes of left atrial structure will also be evaluated at 3 months Our central hypothesis is that SGLT2i will reduce the AF burden after catheter ablation
Sodium-glucose cotransporter 2 inhibitors SGLT2i are a new class of diabetic drugs and large clinical trials have established their multiple cardiovascular benefits Several studies demonstrated that SGLT2i might reduce AFatrial flutter events among patients with diabetes Our cohort study and meta-analysis demonstrated a lower risk of AF recurrence with the use of SGLT2i among patients with diabetes after AF ablation However the beneficial effects of SGLT2i in patients after AF catheter ablation without current indications for SGLT2i were uncertain
In this study we aim to evaluate the effect of dapagliflozin on AF burden Patients with persistent AF undergoing initial catheter ablation without diabetes at high cardiovascular risk heart failure or chronic kidney disease will be enrolled Patients will be randomly assigned to either the dapagliflozin group 10mgd for 3 months or the control group stratified according to body mass index 24 24kgm2 or left atrial diameter 4545mm
The primary outcome is atrial fibrillation burden calculated as the percentage of of all atrial arrhythmia episodes detected by 7-day single-lead ECG patches at 3 months after ablation Quality of life and echocardiography changes of left atrial structure will also be evaluated at 3 months Our central hypothesis is that SGLT2i will reduce the AF burden after catheter ablation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None