Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06528262
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-25
Brief Title:
Effect of Enavogliflozin on Recurrence of Atrial Fibrillation After Catheter Ablation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
ENavogliflozin And preVention Of Atrial Fibrillation Recurrence After Catheter Ablation for Atrial Fibrillation With Heart Failure ENAVO-AF Prospective Randomized Placebo-controlled Double-blind Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ENAVO-AF
Brief Summary:
Objective The purpose of this study is to determine if there is a difference in the recurrence rate of atrial fibrillation AF between a group of patients with AF and heart failure undergoing catheter ablation who are administered the SGLT2 inhibitor Enavogliflozin and a control group placebo group This study aims to investigate whether SGLT2 inhibitors can prevent the recurrence of AF after the procedure
Background AF is the most common arrhythmia requiring treatment with its prevalence increasing with age In the US AF affected 52 million people in 2010 and is projected to reach 121 million by 2030 In South Korea prevalence rose from 073 in 2006 to 153 in 2015 Early-stage AF patients benefit more from rhythm control therapy than from heart rate control alone as shown by the 2020 EAST-AFNET-4 trial which reported a 21 reduction in adverse cardiovascular events Catheter ablation for rhythm control significantly reduces AF recurrence compared to antiarrhythmic drugs leading to more patients undergoing this procedure AF and heart failure often coexist forming a vicious cycle that exacerbates both conditions and leads to poorer outcomes They share common risk factors like hypertension diabetes ischemic heart disease and valvular disease Heart failure increases left atrial filling pressure and alters intracellular calcium levels raising AF risk Further research is needed on their pathophysiological link SGLT2 inhibitors reduce glucose reabsorption in the kidneys to control hyperglycemia in diabetics and have been shown in large studies DAPA-HF EMPEROR-Reduced to significantly reduce heart failure worsening and cardiovascular mortality regardless of diabetes status These benefits were seen in both HFrEF and HFpEF In the DAPA-HF trial 55 of participants were non-diabetic and reductions in heart failure worsening or cardiovascular death were similar between those with and without diabetes 25 vs 27 Adverse events including volume depletion and renal function decline were not significantly different between diabetic and non-diabetic patients and no hypoglycemia or ketoacidosis occurred in non-diabetic patients Recent studies show SGLT2 inhibitors reduce AF incidence and benefit heart failure A sub-analysis of the DECLARE-TIMI 58 trial reported a 19 reduction in AF risk among diabetic patients with SGLT2 inhibitors Meta-analyses by Okunrintemi and Zheng showed an 18 reduction in AF risk irrespective of diabetes status Interest is growing in the relationship between SGLT2 inhibitors and AF recurrence post-catheter ablation Luo et al reported a nearly 39 reduction in AF recurrence post-ablation with dapagliflozin in diabetic patients Kishima et al found a 49 reduction in AF recurrence post-ablation with SGLT2 inhibitors versus DPP-IV inhibitors in a small prospective randomized study However most studies were retrospective sub-analyses or small-scale studies limited to diabetics Prospective randomized studies involving AF patients regardless of diabetes status are urgently needed for validation
Background AF is the most common arrhythmia requiring treatment with its prevalence increasing with age In the US AF affected 52 million people in 2010 and is projected to reach 121 million by 2030 In South Korea prevalence rose from 073 in 2006 to 153 in 2015 Early-stage AF patients benefit more from rhythm control therapy than from heart rate control alone as shown by the 2020 EAST-AFNET-4 trial which reported a 21 reduction in adverse cardiovascular events Catheter ablation for rhythm control significantly reduces AF recurrence compared to antiarrhythmic drugs leading to more patients undergoing this procedure AF and heart failure often coexist forming a vicious cycle that exacerbates both conditions and leads to poorer outcomes They share common risk factors like hypertension diabetes ischemic heart disease and valvular disease Heart failure increases left atrial filling pressure and alters intracellular calcium levels raising AF risk Further research is needed on their pathophysiological link SGLT2 inhibitors reduce glucose reabsorption in the kidneys to control hyperglycemia in diabetics and have been shown in large studies DAPA-HF EMPEROR-Reduced to significantly reduce heart failure worsening and cardiovascular mortality regardless of diabetes status These benefits were seen in both HFrEF and HFpEF In the DAPA-HF trial 55 of participants were non-diabetic and reductions in heart failure worsening or cardiovascular death were similar between those with and without diabetes 25 vs 27 Adverse events including volume depletion and renal function decline were not significantly different between diabetic and non-diabetic patients and no hypoglycemia or ketoacidosis occurred in non-diabetic patients Recent studies show SGLT2 inhibitors reduce AF incidence and benefit heart failure A sub-analysis of the DECLARE-TIMI 58 trial reported a 19 reduction in AF risk among diabetic patients with SGLT2 inhibitors Meta-analyses by Okunrintemi and Zheng showed an 18 reduction in AF risk irrespective of diabetes status Interest is growing in the relationship between SGLT2 inhibitors and AF recurrence post-catheter ablation Luo et al reported a nearly 39 reduction in AF recurrence post-ablation with dapagliflozin in diabetic patients Kishima et al found a 49 reduction in AF recurrence post-ablation with SGLT2 inhibitors versus DPP-IV inhibitors in a small prospective randomized study However most studies were retrospective sub-analyses or small-scale studies limited to diabetics Prospective randomized studies involving AF patients regardless of diabetes status are urgently needed for validation
Detailed Description:
Study Design Overview
Single-center prospective randomized controlled double-blind study
Patients who consent will be randomly assigned to either the intervention or control group
The intervention group will receive Enavogliflozin 03 mg once daily The control group will receive a placebo in the same form
The administration period will be 36030 days targeting patients hospitalized for AF catheter ablation at Severance Hospital or those who have undergone the procedure within the past three months
Target participants 195 in the experimental group SGLT2 inhibitor group 195 in the control group placebo group totaling 390 participants
Regular standard ECG examinations will be conducted at 1 3 6 and 12 months post-procedure and as needed based on symptoms
Wearable ECG patch 8-14 days tests will be conducted at 3 6 and 12 months follow-up visits
Comparison of AF recurrence rates from 3 months to 1 year post-catheter ablation
Comparison of AF burden from catheter ablation up to 1 year post-procedure
Single-center prospective randomized controlled double-blind study
Patients who consent will be randomly assigned to either the intervention or control group
The intervention group will receive Enavogliflozin 03 mg once daily The control group will receive a placebo in the same form
The administration period will be 36030 days targeting patients hospitalized for AF catheter ablation at Severance Hospital or those who have undergone the procedure within the past three months
Target participants 195 in the experimental group SGLT2 inhibitor group 195 in the control group placebo group totaling 390 participants
Regular standard ECG examinations will be conducted at 1 3 6 and 12 months post-procedure and as needed based on symptoms
Wearable ECG patch 8-14 days tests will be conducted at 3 6 and 12 months follow-up visits
Comparison of AF recurrence rates from 3 months to 1 year post-catheter ablation
Comparison of AF burden from catheter ablation up to 1 year post-procedure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None