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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024326
Receipt No. R000027443
Scientific Title Effecy and Safety of Sodium-Glucose Cotransporter 2 (SGLT2) Inhibitors on Atrial Fibrillation
Date of disclosure of the study information 2016/10/07
Last modified on 2017/03/14

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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 Enrolling by invitation
Date of protocol fixation
2017 Year 03 Month 14 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 15 Day
Last follow-up date
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
2017 Year 03 Month 14 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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