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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001652
Receipt No. R000001992
Scientific Title A randomized controlled trial for low-dose continuous Infusion of human atrial natriuretic peptide for cardiac dysfunction undergoing cardiac surgery
Date of disclosure of the study information 2009/01/23
Last modified on 2014/10/27

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Basic information
Public title A randomized controlled trial for low-dose continuous Infusion of human atrial natriuretic peptide for cardiac dysfunction undergoing cardiac surgery
Acronym NU-HIT trial for LVD
Scientific Title A randomized controlled trial for low-dose continuous Infusion of human atrial natriuretic peptide for cardiac dysfunction undergoing cardiac surgery
Scientific Title:Acronym NU-HIT trial for LVD
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 continuous low-dose administration of hANP for cardiac dysfunction during and after caridac surgery in attenuating ischemia- reperfusion injury and suppressing left ventricular remodeling.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes Early postoperative outcome(mortality and complications)
Long-term results(cardiac death-and events-free rate, overall survival rate after surgery))
Key secondary outcomes cardiac function(UCG, BNP)
renal function (sCr,eGFR,Maximum sCr,Increase of Cr,(pre-max. sCr) > 0.3 mg/dl)
ANP, renin, anigotensin-II, aldsterone

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
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 Preoperative cardiac dysfunction (ejection fraction<40%)
Patient undergoing cardiac surgery
Patients from whom informed consent was obtained
Key exclusion criteria cardiogenic shock
renal dysfunction with hemodyalysis
Target sample size 130

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 Oyagichi kami-machi, Itabashi-ku, Tokyo
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
2009 Year 01 Month 23 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
1997 Year 03 Month 10 Day
Date of IRB
Anticipated trial start date
1997 Year 03 Month 01 Day
Last follow-up date
2011 Year 03 Month 01 Day
Date of closure to data entry
2011 Year 05 Month 01 Day
Date trial data considered complete
2011 Year 06 Month 01 Day
Date analysis concluded
2011 Year 10 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 01 Month 23 Day
Last modified on
2014 Year 10 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001992

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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