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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042603
Receipt No. 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

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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
Email 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
Email kennosuke.atmm3@gmail.com

Sponsor
Institute Showa University Northern Yokohama Hospital
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 Ethics Committee in Showa University Northern Yokohama Hospital
Address 35-1, Chigasakichuo, Tsuzuki, Yokohama, Kanagawa
Tel 045-949-7000
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048615

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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