UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000055056 |
|---|---|
| Receipt number | R000062874 |
| 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. |
| Date of disclosure of the study information | 2024/07/24 |
| Last modified on | 2024/07/24 07:16:29 |
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Basic information
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
Condition
Heart failure and persistent atrial fibrillation patients without type-2 diabetes
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Assessment
Primary outcomes
1. Atrial tachyarrhythmia events during 1-year follow-up after catheter ablation
2. Death/Heart hospitalization
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
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
Eligibility
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
Research contact person
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
mharada@fujita-hu.ac.jp
Public contact
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
mharada@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fujita Health University
Address
1-98 Dengakugakubo Kutsukakecho Toyoake Aichi Japan
Tel
0562-93-2312
mharada@fujita-hu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 07 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
110
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
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
Other related information
Management information
Registered date
| 2024 | Year | 07 | Month | 24 | Day |
Last modified on
| 2024 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000062874
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