UMIN-CTR Clinical Trial

Public title

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

Acronym

NODACH-SGLT2 Study

Scientific Title

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

Scientific Title:Acronym

NODACH-SGLT2 Study

Region

Japan

Condition

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

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To examine the impact of sodium-glucose cotransporter 2 inhibitors (SGLT2is) on outcomes of catheter ablation for atrial fibrillation in heart failure patients without type-2 diabetes.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

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

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

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.

Interventions/Control_2

Control arm: patients were observed without SGLT2is treatment during periprocedural period of catheter ablation.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<

Age-upper limit

85

years-old

>=

Gender

Male and Female

Key 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.

Key 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.

Target sample size

110

Name of lead principal investigator

1st name	Masahide
Middle name
Last name	Harada

Organization

Fujita Health University

Division name

Department of Cardiology

Zip code

4701192

Address

1-98 Dengakugakubo Kutsukakecho Toyoake Aichi Japan

TEL

0562-93-2312

Email

mharada@fujita-hu.ac.jp

Name of contact person

1st name	Masahide
Middle name
Last name	Harada

Organization

Fujita Health University

Division name

Department of Cardiology

Zip code

4701192

Address

1-98 Dengakugakubo Kutsukakecho Toyoake Aichi Japan

TEL

0562-93-2312

Homepage URL

Email

mharada@fujita-hu.ac.jp

Institute

Fujita Health University

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Fujita Health University

Address

1-98 Dengakugakubo Kutsukakecho Toyoake Aichi Japan

Tel

0562-93-2312

Email

mharada@fujita-hu.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2024

Year

07

Month

24

Day

URL releasing protocol

DOI: 10.1016/j.ijcard.2024.132954

Publication of results

Published

URL related to results and publications

DOI: 10.1016/j.ijcard.2024.132954

Number of participants that the trial has enrolled

110

Results

This study evaluated periprocedural SGLT2 inhibitor therapy in 102 heart failure patients with persistent atrial fibrillation without diabetes. The SGLT2 inhibitor group showed significantly lower left atrial pressure (9.3 (SD 4.8) vs 12.1 (SD 6.6 mmHg), p<0.01) and lower NT-proBNP at 1 month. Arrhythmia-free survival was higher both during the blanking period (92% vs 62%) and at 1 year (89% vs 74%). Periprocedural SGLT2 inhibitor therapy may improve catheter ablation outcomes.

Results date posted

2026

Year

01

Month

24

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

A total of 102 patients with persistent atrial fibrillation (PeAF) and heart failure without type 2 diabetes mellitus were enrolled. The mean age was 71 (SD 9) years, and 30% of the patients were female. The mean CHADS2 score was 2.2 (SD 1.0) and the mean CHA2DS2-VASc score was 3.3 (SD 1.4).

Regarding heart failure phenotype, 71% of patients had HF with preserved ejection fraction (HFpEF), 19% had HF with mildly reduced ejection fraction (HFmEF), and 11% had HF with reduced ejection fraction (HFrEF). The mean left ventricular ejection fraction was 53 (SD 10) %. The mean left atrial diameter was 42.7 (SD 5.7) mm and the left atrial volume index was 49.0 (SD 13.7) mL/m2. Baseline NT-proBNP level was 1712 (SD 1138) pg/mL.

Hypertension was present in 53% of patients, and 11% had a history of stroke or transient ischemic attack. Beta-blockers were prescribed in 80%, ACE inhibitors or ARBs in 48%, and ARNIs in 11%. Diuretics were used in 38% of patients.

There were no significant differences in demographic characteristics, cardiac function, atrial size, heart failure severity, comorbidities, or background medications between the SGLT2 inhibitor group (n=51) and the non-SGLT2 inhibitor group (n=51)

Participant flow

Between June 2022 and November 2023, a total of 160 patients with persistent atrial fibrillation (PeAF) and heart failure were screened. Fifty-two patients were excluded due to insufficient data (n=4), structural heart disease (n=8), type 2 diabetes mellitus (n=21), valvular heart disease (n=4), low body mass index (n=2), chronic renal failure (n=3), history of urinary tract infection (n=2), and prior SGLT2 inhibitor use (n=8). As a result, 108 patients met the eligibility criteria and were enrolled.

After enrollment, patients were allocated in a 1:1 ratio to the SGLT2 inhibitor group (n=54) or the non-SGLT2 inhibitor group (n=54). Six patients (3 in each group) were excluded due to unavailable left atrial pressure measurements. Finally, 51 patients in the SGLT2 inhibitor group and 51 patients in the non-SGLT2 inhibitor group (total n=102) were included in the final analysis. All patients completed the 1-year follow-up.

Adverse events

During the study period, no heart failure hospitalizations were observed in either group. One patient in the SGLT2 inhibitor group died of unknown cause at 9 months after the procedure. No autopsy was performed, and no definite cardiovascular deaths were identified in either group.

There were no serious adverse drug-related events attributable to SGLT2 inhibitor therapy, including severe dehydration or serious infections.

Outcome measures

Primary Endpoint

Recurrence of atrial tachyarrhythmia (atrial fibrillation, atrial flutter, or atrial tachycardia lasting 30 seconds or more) during the 1-year follow-up period after the 3-month blanking period following catheter ablation

Secondary Endpoints

Recurrence of atrial tachyarrhythmia lasting 30 seconds or more during the 3-month blanking period

Left atrial pressure (LAP)

Serial changes in serum NT-proBNP levels

Composite endpoint of all-cause death, cardiovascular death, and heart failure hospitalization

Plan to share IPD

IPD sharing Plan description

Recruitment status

Main results already published

Date of protocol fixation

2022

Year

04

Month

01

Day

Date of IRB

2020

Year

12

Month

15

Day

Anticipated trial start date

2022

Year

06

Month

01

Day

Last follow-up date

2024

Year

10

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2024

Year

07

Month

24

Day

Last modified on

2026

Year

01

Month

24

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062874