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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000005353
Receipt No. R000005811
Scientific Title the study about the improvement of the outcome of catheter ablation for atrial fibrillation to the patients with hypertension
Date of disclosure of the study information 2011/05/01
Last modified on 2017/04/06

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Basic information
Public title the study about the improvement of the outcome of catheter ablation for atrial fibrillation to the patients with hypertension
Acronym the study about the improvement of the outcome of catheter ablation for atrial fibrillation
Scientific Title the study about the improvement of the outcome of catheter ablation for atrial fibrillation to the patients with hypertension
Scientific Title:Acronym the study about the improvement of the outcome of catheter ablation for atrial fibrillation
Region
Japan

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

Objectives
Narrative objectives1 to clarify the efficacy of mineralocorticoid receptor antagonist eplerenone for the outcome of catheter ablation for atrial fibrillation to the patients with hypertension
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the recurrence of atrial fibrillation after catheter ablation for atrial fibrillation
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Eplerenone was administered at a dose of 50mg daily.
Interventions/Control_2 An antihypertensive drug except for eplerenone.
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 the patients with drug refractory atrial fibrillation and hypertension
Key exclusion criteria Patients were excluded if they had contraindications to ARBs and/or aldosterone inhibitor; had recently (within the previous 3 months) had an acute myocardial infarction, coronary bypass operation, or percutaneous
coronary intervention; had clinically significant valvular disease; had thyroid dysfunction; were pregnant

Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazutaka Aonuma
Organization Institute of Clinical Medicine, Graduate School of Comprehensive Human Sciences, University of Tsukuba
Division name Department of Cardiology
Zip code
Address 1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL 029-853-3142
Email kaonuma@md.tsukuba.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazutaka Aonuma
Organization Graduate School of Comprehensive Human Sciences, University of Tsukuba
Division name Department of Cardiology
Zip code
Address 1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL 029-853-3142
Homepage URL
Email kaonuma@md.tsukuba.ac.jp

Sponsor
Institute Institute of Clinical Medicine, Graduate School of Comprehensive Human Sciences, University of Tsukuba
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
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 筑波大学附属病院(茨城県)

Other administrative information
Date of disclosure of the study information
2011 Year 05 Month 01 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 Terminated
Date of protocol fixation
2011 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 05 Month 01 Day
Last follow-up date
2014 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 03 Month 31 Day
Last modified on
2017 Year 04 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005811

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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