Skip to content

Impact of Sodium-Glucose Cotransporter 2 Inhibitors on Outcomes of Catheter Ablation for Atrial Fibrillation in Heart Failure Patients without Type-2 Diabetes.

Impact of Sodium-Glucose Cotransporter 2 Inhibitors on Outcomes of Catheter Ablation for Atrial Fibrillation in Heart Failure Patients without Type-2 Diabetes. - NODACH-SGLT2 Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000055056
Enrollment
110
Registered
2024-07-24
Start date
2022-06-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart failure and persistent atrial fibrillation patients without type-2 diabetes

Interventions

Treatment arm: patients were to receive sodium-glucose cotransporter 2 inhibitors (SGLT2is) for more than one month prior to catheter ablation and were continued during 1-year follow-up. Control arm:

Sponsors

Fujita Health University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: The inclusion criteria are as follows and patients who met all inclusion criteria were eligible: patients with PeAF who were referred to our outpatient department; patients with clinical symptoms, history, and findings that suspect HF based on the Japanese Circulation Society Guideline; patients with 400 pg/ml or more of the serum N-terminal prohormone of brain natriuretic peptide NT-proBNP levels for diagnosing HF.

Exclusion criteria

Exclusion criteria: Exclusion criteria are as follows: patients who required emergency hospitalization at referral. patients with previously diagnosed structural heart disease, cardiac sarcoidosis, and severe valvular heart disease; patients with very severe HF who were classified into New York Heart Association (NYHA) functional class IV. patients who had potential risk of the drug adverse effect of SGLT2is (dehydration, genital infections, etc. patients under 18 years old and those who were pregnant; patients with creatinine clearance (calculated by Cockcroft-Gault formula) <30 mL/min and those on hemodialysis; patients who had LA appendage thrombus on transesophageal echocardiography before the procedure; patients with mechanical valves; patients with already-diagnosed T2DM who took hypoglycemic medications; patients who were diagnosed with T2DM at enrollment (HbA1c: 6.5% or more) patients who took SGLT2is for HF treatment before enrollment.

Design outcomes

Primary

MeasureTime frame
1. Atrial tachyarrhythmia events during 1-year follow-up after catheter ablation 2. Death/Heart hospitalization

Countries

Japan

Contacts

Public ContactMasahide Harada

Fujita Health University Department of Cardiology

mharada@fujita-hu.ac.jp0562-93-2312

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026