UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004048 |
|---|---|
| Receipt number | R000004881 |
| Scientific Title | Effects of long-term administration of human atrial natriuretic peptide in patients with acute heart failure |
| Date of disclosure of the study information | 2010/09/01 |
| Last modified on | 2010/08/16 16:48:03 |
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Basic information
Public title
Effects of long-term administration of human atrial natriuretic peptide in patients with acute heart failure
Acronym
Effects of long-term administration of human atrial natriuretic peptide in patients with acute heart failure
Scientific Title
Effects of long-term administration of human atrial natriuretic peptide in patients with acute heart failure
Scientific Title:Acronym
Effects of long-term administration of human atrial natriuretic peptide in patients with acute heart failure
Region
| Japan |
Condition
Condition
acute heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of long-term administration of human atrial natriuretic peptide for cardiac function, renal function and rehospitalization rate in patients with acute heart failure
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Improvements of left ventricular ejection fraction, concentration of serum creatinine, estimated GFR and BUN at discharge and 6months after discharge
2) Improvements of rehospitalization rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
five days administration of human atrial natriuretic peptide
Interventions/Control_2
more than ten days administration of human atrial natriuretic peptide
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Inpatients with acute congestive heart failure
Key exclusion criteria
1) Patients with a history of hypersensitivity to carperitide
2) Patients with severe hypotention or cardioganic shock
3) Patients with dominant rightventricular heart failure
4) Patients with dehydration
5) Patients with systolic blood pressure <100mmHg
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Minoru Yoshiyama |
Organization
Osaka city university graduate school of medicine
Division name
Department of cardiology
Zip code
Address
1-4-3, Asahimachi Abenoku, Osaka
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akihisa Hanatani |
Organization
Osaka city university graduate school of medicine
Division name
Department of cardiology
Zip code
Address
TEL
06-6645-3801
Homepage URL
Sponsor or person
Institute
Department of cardiology
Osaka city university graduate school of medicine
Institute
Department
Personal name
Funding Source
Organization
Department of cardiology
Osaka city university graduate school of medicine
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
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 09 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2010 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 06 | 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
| 2010 | Year | 08 | Month | 16 | Day |
Last modified on
| 2010 | Year | 08 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004881
