UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017199 |
|---|---|
| Receipt number | R000019947 |
| Scientific Title | Assessment of Arterial Enothelial Functon by using ASV in Patients with Chronic Heart Failure |
| Date of disclosure of the study information | 2015/04/20 |
| Last modified on | 2015/11/25 19:13:50 |
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Basic information
Public title
Assessment of Arterial Enothelial Functon by using ASV in Patients with Chronic Heart Failure
Acronym
Improving Arterial Endothelial Function by ASV
Scientific Title
Assessment of Arterial Enothelial Functon by using ASV in Patients with Chronic Heart Failure
Scientific Title:Acronym
Improving Arterial Endothelial Function by ASV
Region
| Japan |
Condition
Condition
Chronic Heart Failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Assessment of arterial endotherial function by using ASV therapy in patients with chronic heart failure
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Assessment of FMD(Flow -Mediated Dilation) in patients with heart failure before and post-3-6 month by using ASV
Key secondary outcomes
Comparison of acute effects on FMD between control and CHF Group by using ASV
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are 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
Adaptive servo ventilation was recieved to support spontaneous respiration in patients with heart failure only at study day
Interventions/Control_2
FMD was used for evalating the endothlial function.
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
the erolled people who can understand the inormation and explanation from the docotors engaged in the present study
CHF Group
1.Prior hospitalization due to CHF and more than and NYHA2
2.LVEF more than and 45% based on 2D echocardiogram
Control Group
1.NYHA1 or asymptomatic
2.no organic heart disease
Key exclusion criteria
1. those with unconsiousness status
2. those with severe neurological deficits and pulmonary diseases
3. patients who can not perform FMD
4. patients who can not get Informed consent
Target sample size
70
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, Japan
TEL
011-706-6970
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
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University Graduate School of Medicine
Organization
Division
Category of Funding Organization
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 | 04 | Month | 20 | 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
Though there are no significant change between both groups in endothrlial function by using FMD, brachial artery diameters became more increased in CHF group than Control group.
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
| 2012 | Year | 07 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2015 | Year | 12 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 04 | Month | 20 | Day |
Last modified on
| 2015 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019947
| 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 |
