UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003974 |
|---|---|
| Receipt number | 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 20:22:31 |
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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
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
sirayama@koto.kpu-m.ac.jp
Sponsor or person
Institute
KPUM KABUTO-AF study investigators
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004791
