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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003974
Receipt No. R000004791
Scientific Title Kyoto Aldosterone Blocker Upstream Therapy on Atrial Fibrillation Trial (KABUTO-AF Trial)
Date of disclosure of the study information 2010/08/01
Last modified on 2012/07/31

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Basic information
Public title Kyoto Aldosterone Blocker Upstream Therapy on Atrial Fibrillation Trial (KABUTO-AF Trial)
Acronym Kyoto Aldosterone Blocker Upstream Therapy on Atrial Fibrillation Trial
(KABUTO-AF Trial)

Scientific Title Kyoto Aldosterone Blocker Upstream Therapy on Atrial Fibrillation Trial (KABUTO-AF Trial)
Scientific Title:Acronym Kyoto Aldosterone Blocker Upstream Therapy on Atrial Fibrillation Trial
(KABUTO-AF Trial)

Region
Japan

Condition
Condition Paroxysmal af with hypertension and implanted pacemakers
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of the prospective study was to evaluate the anti-arrhythmic potential of selective aldosterone blocker (Eplerenone) in patients with paroxysmal Af using implanted device monitoring.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Percentage of documented Af burden (%)
Number of documented Af attack during 6 months
Progression to permanent Af
Key secondary outcomes 6-month major adverse cardiac and cerebral event (MACCE) rate
All cause death, cardiac death, myocardial infarction, PCI and/or CABG, Stroke, CHF requiring hospitalization,, aorta&peripheral artery disease, hemodialysis
CRP, WBC, fibrinogen, aldosterone, renin, BNP,

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation
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 50-100mg for 6-month
Interventions/Control_2 conventional medication without eplerenone for 6-month
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
90 years-old >=
Gender Male and Female
Key inclusion criteria DDD pacemaker(Device implantation>210 days)
Documented paroxysmal Af
Af burden(>2% &<90%)
High BP(130-139/85-89mmHg)and Hypertension(140=or</90=or< mmHg)
Age>20-90years
Written informed consent
Key exclusion criteria Previous administration of eplerenone
Low EF<40%
Symptomatic heart failure (NYHA>II)
Enlarged LAD>55mm
Valvular disease requiring surgical
operation
chronic Af
ACS<30 days
Cardiogenic shock
Contraindication for Eplerenone
Intolerance to Eplerenone
Scheduled Cardiac surgery within 1year
Scheduled Catheter ablation within 1 year
Symptomatic arterial hypotension
Secondary hypertension
ICD
pacemaker program change for af suppression options
pregnancy
Chronic inflammatory disease
Malignancy
Severe infection
Life expectancy<1years
eGFR<40
Dialysis
Severe Liver dysfunction
Drug addiction
Alcohol abuse
Inability to give informed consent
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroaki Matsubara, Takeshi Shirayama
Organization KPUM KABUTO-AF study investigators

Division name Kyoto Prefectural University of Medicine(KPUM),Dept of Cardiology
Zip code
Address 465 Kajii-cho Kawaramachi-dori Hirokoji Kamigyo-ku Kyoto Japan 602-8566
TEL 075-251-5511
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiroaki Matsubara, Takeshi Shirayama
Organization KPUM KABUTO-AF study investigators
Division name Kyoto Prefectural University of Medicine(KPUM), Dept of Cardiology
Zip code
Address 465 Kajii-cho Kawaramachi-dori Hirokoji Kamigyo-ku Kyoto Japan 602-8566
TEL 075-251-5511
Homepage URL
Email sirayama@koto.kpu-m.ac.jp

Sponsor
Institute KPUM KABUTO-AF study investigators
Institute
Department

Funding Source
Organization Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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 京都府立医科大学 (京都府)

Other administrative information
Date of disclosure of the study information
2010 Year 08 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 Completed
Date of protocol fixation
2010 Year 04 Month 30 Day
Date of IRB
Anticipated trial start date
2010 Year 07 Month 01 Day
Last follow-up date
2012 Year 03 Month 31 Day
Date of closure to data entry
2012 Year 03 Month 31 Day
Date trial data considered complete
2012 Year 03 Month 31 Day
Date analysis concluded
2012 Year 04 Month 30 Day

Other
Other related information

Management information
Registered date
2010 Year 07 Month 31 Day
Last modified on
2012 Year 07 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004791

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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