UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042603 |
|---|---|
| Receipt number | R000048615 |
| Scientific Title | The Multicenter Prospective Randomized Controlled Trial Evaluating Efficacy of Dapagliflozin to Improve Long-Term Outcome of Catheter Ablation for Atrial Fibrillation in Patients with Heart Failure |
| Date of disclosure of the study information | 2020/11/30 |
| Last modified on | 2020/11/30 22:09:40 |
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Basic information
Public title
The Multicenter Prospective Randomized Controlled Trial Evaluating Efficacy of Dapagliflozin to Improve Long-Term Outcome of Catheter Ablation for Atrial Fibrillation in Patients with Heart Failure
Acronym
DARAF trial
Scientific Title
The Multicenter Prospective Randomized Controlled Trial Evaluating Efficacy of Dapagliflozin to Improve Long-Term Outcome of Catheter Ablation for Atrial Fibrillation in Patients with Heart Failure
Scientific Title:Acronym
DARAF trial
Region
| Japan |
Condition
Condition
Atrial Fibrillation in Patients with Heart Failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to assess the efficacy of Dapagliflozin to improve the long-term outcome including recurrent atrial fibrillation, supraventricular premature contraction, and worsening heart failure following catheter ablation for atrial fibrillation in patients with heart failure.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Event free survival rate from atrial fibrillation and tachycardia following catherter ablation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
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
Patients are treated with Dapagliflozin for one year weeks following the catheter ablation
Interventions/Control_2
Patients are treated without Dapagliflozin for one year weeks following 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
Atrial fibrillation in patients with heart failure who undergo catheter ablation for atrial fibrillation.
All patients are treated with oral anti-coagulants before the procedure.
Key exclusion criteria
Patients who are intolerant for SGLT-2 inhibitor
Patients with renal insufficiency (estimated GFR < 30)
When the attending physician consider inappropriate to enroll the patient in the study
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kennosuke |
| Middle name | |
| Last name | Yamashita |
Organization
Showa University Northern Yokohama Hospital
Division name
Department of Cardiovascular Medicine
Zip code
224-8503
Address
35-1, Chigasakichuo, Tsuzuki, Yokohama, Kanagawa
TEL
045-949-7000
kennosuke.atmm3@gmail.com
Public contact
Name of contact person
| 1st name | Kennosuke |
| Middle name | |
| Last name | Yamashita |
Organization
Showa University Northern Yokohama Hospital
Division name
Department of Cardiovascular Medicine
Zip code
224-8503
Address
35-1, Chigasakichuo, Tsuzuki, Yokohama, Kanagawa
TEL
045-949-7000
Homepage URL
kennosuke.atmm3@gmail.com
Sponsor or person
Institute
Showa University Northern Yokohama Hospital
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
Ethics Committee in Showa University Northern Yokohama Hospital
Address
35-1, Chigasakichuo, Tsuzuki, Yokohama, Kanagawa
Tel
045-949-7000
kennosuke@med.showa-u.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
| 2020 | Year | 11 | Month | 30 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 11 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | 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
| 2020 | Year | 11 | Month | 30 | Day |
Last modified on
| 2020 | Year | 11 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048615
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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