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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001464
Receipt No. R000001780
Scientific Title Influence of angiotensin receptor blocker and angiotensin-Converting Enzyme on renin-angiotensin-aldosterone system and left ventricular remodeling after cardiac surgery
Date of disclosure of the study information 2010/10/29
Last modified on 2014/10/29

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Basic information
Public title Influence of angiotensin receptor blocker and angiotensin-Converting Enzyme on renin-angiotensin-aldosterone system and left ventricular remodeling after cardiac surgery
Acronym Influence of angiotensin receptor blocker and angiotensin-Converting Enzyme on renin-angiotensin-aldosterone system and left ventricular remodeling after cardiac surgery
Scientific Title Influence of angiotensin receptor blocker and angiotensin-Converting Enzyme on renin-angiotensin-aldosterone system and left ventricular remodeling after cardiac surgery
Scientific Title:Acronym Influence of angiotensin receptor blocker and angiotensin-Converting Enzyme on renin-angiotensin-aldosterone system and left ventricular remodeling after cardiac surgery
Region
Japan

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

Objectives
Narrative objectives1 To reserch the effects of ARB or ACE-I administration of hANP after caridac surgery in influence for renin-angiotensin-aldosterone system and suppressing left ventricular remodeling.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes long-term result
cardiac event
Key secondary outcomes UCG (EF, LVDd, LVDs)
BNP
renin, angiotensin, aldosterone

Base
Study type Interventional

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

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 postoperative administration of ARB
Interventions/Control_2 postoperative administration of ACE-I
Interventions/Control_3 postoperative non-administration of ARB or ACE-I
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 Patient undergoing CABG
Patients from whom informed consent was obtained
Key exclusion criteria preoperativerenal impairment(Cr>1.3mg/dl)
preoperative cardiogenic shock
Target sample size 200

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 03-3972-8111
Email asezai.med@gmail.com

Public contact
Name of contact person
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 03-3972-8111
Homepage URL
Email asezai.med@gmail.com

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) a grant for the 60th anniversary of the Alumni Association of Nihon University School of Medicine and for the 50th anniversary of the foundation of Nihon University School of Medicine.

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

Other administrative information
Date of disclosure of the study information
2010 Year 10 Month 29 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 11 Month 10 Day
Date of IRB
Anticipated trial start date
2001 Year 11 Month 01 Day
Last follow-up date
2008 Year 12 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
2010 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2008 Year 10 Month 29 Day
Last modified on
2014 Year 10 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001780

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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