UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024326 |
|---|---|
| Receipt number | 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 | 2020/04/12 09:29:42 |
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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
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
kishima@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo collage of medicine
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
Address
Tel
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027443
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