UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008637 |
|---|---|
| Receipt number | R000010151 |
| Scientific Title | The efficacy and safety of ASV therapy for acute heart failure |
| Date of disclosure of the study information | 2012/08/13 |
| Last modified on | 2015/02/07 09:20:01 |
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Basic information
Public title
The efficacy and safety of ASV therapy for acute heart failure
Acronym
ASV for acute heart failure
Scientific Title
The efficacy and safety of ASV therapy for acute heart failure
Scientific Title:Acronym
ASV for 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 efficacy and safety of ASV therapy for acute heart failure
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
death in 7 days, 30 days
Key secondary outcomes
intubation, dyspnea score, blood gas analysis
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
application of ASV for 2 hours after arrival
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) written consent
2) clinical diagnosis of AHF
3) pH <7.35
Key exclusion criteria
1) shceduled invasive procedure i.e. surgery, PCI
2) general contraindication of ASV
tendancy to vomit
inablity to swallow
pneumothorax or pneumomediatinum
recent head trauma or surgery
chronic hypoventilation
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shintaro NAKANO |
Organization
Saitama Medical University, International Medical Center
Division name
Cardiology
Zip code
Address
1397-1, Yamane, Hidakashi, Saitama
TEL
090482798924
snakano@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shintaro Nakano |
Organization
Saitama Medical University, International Medical Center
Division name
Cardiology
Zip code
Address
1397-1, Yamane, Hidaka, Saitama
TEL
09048278924
Homepage URL
snakano@gmail.com
Sponsor or person
Institute
Saitama Medical University, International Medical Center
Institute
Department
Personal name
Funding Source
Organization
nil
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
| 2012 | Year | 08 | Month | 13 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 07 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | Month | 11 | Day |
Last follow-up date
| 2015 | Year | 02 | Month | 07 | Day |
Date of closure to data entry
| 2015 | Year | 02 | Month | 07 | Day |
Date trial data considered complete
| 2015 | Year | 02 | Month | 07 | Day |
Date analysis concluded
| 2015 | Year | 02 | Month | 07 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 08 | Month | 07 | Day |
Last modified on
| 2015 | Year | 02 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010151
