UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001652 |
|---|---|
| Receipt number | 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 13:17:26 |
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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
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
asezai.med@gmail.com
Sponsor or person
Institute
Nihon University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001992
