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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003958
Receipt No. R000004770
Scientific Title Effect of hANP for prevention of atrial fibrillation after CABG: a randomised controlled trial
Date of disclosure of the study information 2010/07/28
Last modified on 2012/02/15

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Basic information
Public title Effect of hANP for prevention of atrial fibrillation after CABG: a randomised controlled trial
Acronym NU-HIT trial for prevention of Af
Scientific Title Effect of hANP for prevention of atrial fibrillation after CABG: a randomised controlled trial
Scientific Title:Acronym NU-HIT trial for prevention of Af
Region
Japan

Condition
Condition myocardial infarction, angina
Classification by specialty
Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the anti-arrhythmic effect of hANP in patients with atrial fibrillation after cardiac surgery
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes Incidence of postoperative atrial fibrillation
Key secondary outcomes ANP, renin, anigotensin-II, aldsterone
1)Age
2)renin, anigotensin-II, aldsterone
3)ANP, BNP, cyclic GMP
4)CK-MB, H-FABP
5)CRP
6)mortality, complication

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Perioperative administration of hANP
Interventions/Control_2 Perioperative non-administration of hANP
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 Patient undergoing isolated CABG
patients from whom informed consent was obtained
Key exclusion criteria past of arrhythmia
sinus bradycardia at rest (<50/min)
second -or third-degree AV block
clinical hypothyroidism or hyperthyroidism
Doctor's decision not to register to this regimen
Target sample size 700

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akira Sezai
Organization Nihon University School of Medicine
Division name Department of Cardiovascular Surgery
Zip code
Address 30-1 Oyaguchi kami-machi, Itabashi-ku, Tokyo, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Nihon University School of Medicine
Division name Department of Cardiovascular Surgery
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Nihon University school of medicine
Institute
Department

Funding Source
Organization self funding
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 日本大学板橋病院

Other administrative information
Date of disclosure of the study information
2010 Year 07 Month 28 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
2001 Year 10 Month 10 Day
Date of IRB
Anticipated trial start date
2001 Year 11 Month 01 Day
Last follow-up date
2010 Year 08 Month 01 Day
Date of closure to data entry
2010 Year 12 Month 01 Day
Date trial data considered complete
2010 Year 12 Month 01 Day
Date analysis concluded
2011 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 07 Month 28 Day
Last modified on
2012 Year 02 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004770

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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