UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006240 |
|---|---|
| Receipt number | R000007383 |
| Scientific Title | Effects of combination therapy with carperitide and low dose of dopamine on diuretic effects and renal functions in acute heart failure |
| Date of disclosure of the study information | 2011/08/27 |
| Last modified on | 2012/11/27 14:22:57 |
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Basic information
Public title
Effects of combination therapy with carperitide and low dose of dopamine on diuretic effects and renal functions in acute heart failure
Acronym
Effects of combination therapy with carperitide and dopamine in acute heart failure
Scientific Title
Effects of combination therapy with carperitide and low dose of dopamine on diuretic effects and renal functions in acute heart failure
Scientific Title:Acronym
Effects of combination therapy with carperitide and dopamine in acute heart failure
Region
| Japan |
Condition
Condition
acute heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examine effects of combination therapy with carperitide and low dose of dopamine on diuretic effects and renal functions in acute heart failure.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
renal function
urine volume
Key secondary outcomes
renin, aldosterone, BNP, Troponin-T, creatinine, urinary L-FABP, urinary 8-OHdG
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
carperitide and dopamine
Interventions/Control_2
carperitide and furosemide
Interventions/Control_3
carperitide alone
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
subjects hospitalized with acute heart failure diagnosed by Framingham's criteria
Key exclusion criteria
on admission,
1)systolic blood pressure<90mmHg
2)severe liver injury
3)severe renal failure(Cr>2.0mg/dl)
4)acute myocardial infarction within 3 months
5)history of adverse reactions to carperitide, dopamine or furosemide
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masataka Kamiya |
Organization
Nippon medical school
Division name
The first department of internal medicine
Zip code
Address
#1-1-5, Sendagi, Bunkyo-ku, Tokyo, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masataka Kamiya |
Organization
Fraternity memorial hospital
Division name
internal medicine
Zip code
Address
#2-1-11, yokoami, sumidaku, Tokyo, Japan
TEL
03-3625-6381
Homepage URL
Sponsor or person
Institute
Nippon medical school
Institute
Department
Personal name
Funding Source
Organization
Nippon medical school
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
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
同愛記念病院(東京都)
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 08 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2010 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 08 | Month | 27 | Day |
Last modified on
| 2012 | Year | 11 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007383
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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