UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A randomized controlled trial for low-dose continuous Infusion of human atrial natriuretic peptide for high risk patients undergoing cardiac surgery
Title of the study (Brief title)	NU-HIT trial for High risk patients
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 high risk patients during and after caridac surgery.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase III

Assessment
Primary outcomes	major adverse cardiovascular and cerebrovascular events (MACCE)
Key secondary outcomes	1) postoperative death (early, late) 2) MACCE + hemodialysis (HD) 3) serum creatinine (sCr) and brain natriuretic peptide (BNP) levels at 1 week and 1 year postoperatively.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
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 (0.02ganma)
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	EuroScore>6 point On pump CABG Patients from whom informed consent was obtained
Key exclusion criteria	OPCAB Combined surgery
Target sample size	350

Research contact person
Name of lead principal investigator	Akira Sezai
Organization	Nihon University School of Medicine
Division name	Department of Cardiovascular Surgery
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	Akira Sezai
Organization	Nihon University school of medicine
Division name	Department of Cardiovascular Surgery
Address	30-1 Oyaguchi kami-machi, Itabasi-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)

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 11 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	1997 Year 03 Month 01 Day
Anticipated trial start date	1997 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2010 Year 11 Month 10 Day
Last modified on	2018 Year 03 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005421