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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | myocardial infarction, angina | |
Classification by specialty |
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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 |
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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 | ||
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Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | Preoperative cardiac dysfunction (ejection fraction<40%)
Patient undergoing cardiac surgery Patients from whom informed consent was obtained |
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Key exclusion criteria | cardiogenic shock
renal dysfunction with hemodyalysis |
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Target sample size | 130 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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) | |
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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 | |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Baseline Characteristics | |
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Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
Date of protocol fixation |
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Other | |
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Management information | |||||||
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Last modified on |
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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 |