UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017384 |
|---|---|
| Receipt number | R000020174 |
| Scientific Title | Acute Effect of ASV on patients with advanced chronic heart failure |
| Date of disclosure of the study information | 2015/05/01 |
| Last modified on | 2015/05/01 20:24:14 |
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Basic information
Public title
Acute Effect of ASV on patients with advanced chronic heart failure
Acronym
Acute Effect of ASV on CHF patients
Scientific Title
Acute Effect of ASV on patients with advanced chronic heart failure
Scientific Title:Acronym
Acute Effect of ASV on CHF patients
Region
| Japan |
Condition
Condition
Heart Failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the acute hemodynamic chage pre and post-ASV therapy in advanced CHF patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the acute hemodynamic chage including presuure of each chamber and cardiac output pre and post-ASV therapy in advanced CHF patients by using Swan-Ganz catheter
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
ASV:Adaptive-servo Ventilation
Interventions/Control_2
Catheterization
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patints needed the cardiac catheterization at the hospitalization at Hokkaido University Hospital
CHF Group
1.NYHA more than and 3
2.LVEF less than and 40%
3.BNP more than and 100pg/ml
Control Group
1.asymptomatic
2.LVEF more than and 60%
3.BNP less than and 100pg/ml
Key exclusion criteria
1.patinets with unconsciouness
2.severe pulmonary dysfunction
3.difficulty of echocardiography performance including informed consent
4.difficulaty of cardiac catheterization
including infromed consent
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Tsutsui |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
Kita 15, Nishi 7, Kita-ku, Sapporo
TEL
011-706-6973
htsutsui@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mamoru Sakakibara |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
Kita 15, Nishi 7, Kita-ku, Sapporo, Japan
TEL
011-706-6973
Homepage URL
mike.s@ninus.ocn.ne.jp
Sponsor or person
Institute
Hokkaido University Graduate School of Medicine, Department of Cardiovascular Medicine
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University Graduate School of Medicine, Department of Cardiovascular 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
| 2015 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
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
Main results already published
Date of protocol fixation
| 2009 | Year | 10 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 12 | 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
| 2015 | Year | 05 | Month | 01 | Day |
Last modified on
| 2015 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020174
| 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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| Registered date | File name |
