UMIN-CTR Clinical Trial

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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