UMIN-CTR Clinical Trial

Basic information
Public title	Effecy and Safety of Sodium-Glucose Cotransporter 2 (SGLT2) Inhibitors on Atrial Fibrillation
Acronym	Effecy and Safety of Sodium-Glucose Cotransporter 2 (SGLT2) Inhibitors on Atrial Fibrillation
Scientific Title	Effecy and Safety of Sodium-Glucose Cotransporter 2 (SGLT2) Inhibitors on Atrial Fibrillation
Scientific Title:Acronym	Effecy and Safety of Sodium-Glucose Cotransporter 2 (SGLT2) Inhibitors on Atrial Fibrillation
Region	Japan

Condition
Condition	atrial fibrillation
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The favorable effects of SGLT2 inhibitor, such as blood pressure, blood glucose levels and body weight, are well documented. However, the impact of SGLT2 inhibitor remains unclear. We hypothesized that SGLT2 inhibitors have a good effects on AF, and investigate efficacy and safety of SGLT2 inhibitor on the outcomes after catheter ablation compared with DPP4 inhibitor.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Primary outcome is recurrence of atrial fibrillation at 12-month after catheter ablation.
Key secondary outcomes	1)Recurrence of atrial fibrillation at 1, 3, 6, and 9-month after catheter ablation 2)Estimated glomerular filtration and creatinine (at 3 and 12-month after catheter ablation) 3)Quolity of life (at 1, 3, 6, and 12-month after catheter ablation) 4)Body weight index (at 1, 3, 6, 9, and 12-month after catheter ablation) 5)Body mass index (at 1, 3, 6, 9, and 12-month after catheter ablation) 6)waist circumference (at 1, 3, 6, 9, and 12-month after catheter ablation) 7)Heart rate at rest (at 1, 3, 6, 9, and 12-month after catheter ablation) 8)Blood pressure (at 1, 3, 6, 9, and 12-month after catheter ablation) 9)The following factors (at 3 and 12-month after catheter ablation) triglyceride, LDL-cholesterol, HDL-cholesterol, fatty acids, Hb, Hct, Cystatin C, CA-125, blood ketone body, renin, aldosterone, Brain natriuretic peptide, Atrial natriuretic peptide, HbA1c, IRI, glycoalbumin, urinary albumin 10)The following echocardiographic findings (at 3 and 12-month after catheter ablation) Left atrial functions Left atrial diameter, Left atrial volume E/e` ratio Left ventricular ejection fraction Velocity time integral Spontaneous echo contrast Left atrial appendage flow velocity 12)Left atrial pressure and low voltage area (during catheter ablation) 13)Cardio Thoracic Ratio (at 12-month after catheter ablation)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	In intervention group, patients are treated with SGLT2 inhibitors for 2-6 weeks before the catheter ablation.
Interventions/Control_2	In control group, patients are treated with DPP4 inhibitor for 2-6 weeks before the 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	20 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Type 2 diabetes mellitus (6.5< HbA1c <10%) patients with non-valvular AF who undergo the catheter ablation. All patients are treated with oral anti-coagulants.
Key exclusion criteria	1. Prior history of stroke / transient ischemic attack within 3-month 2. Valvular AF 3. Prior history of cardiac surgery 4. Chronic kidney disease (eGFR <30)
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Middle name Last name Tohru Masuyama
Organization	Hyogo collage of medicine
Division name	Department of internal medicine, cardiovascular division
Zip code
Address	1- 1 Mukogawa-cho, Nishinomiya 663-8501, Japan.
TEL	0798-45-6111
Email	masuyama@hyo-med.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Hideyuki Kishima
Organization	Hyogo collage of medicine
Division name	Department of internal medicine, cardiovascular division
Zip code
Address	1-1 Mukogawa-cho, Nishinomiya 663-8501, Japan.
TEL	0798-45-6111
Homepage URL
Email	kishima@hyo-med.ac.jp

Sponsor
Institute	Hyogo collage of medicine
Institute
Department

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
Address
Tel
Email

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	2016 Year 10 Month 07 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
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	2017 Year 03 Month 14 Day
Date of IRB	2017 Year 01 Month 26 Day
Anticipated trial start date	2017 Year 03 Month 15 Day
Last follow-up date	2020 Year 03 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 10 Month 06 Day
Last modified on	2020 Year 04 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027443