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Recruitment status Completed
Unique ID issued by UMIN UMIN000017199
Receipt No. 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

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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
Email 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
Email mike.s@ninus.ocn.ne.jp

Sponsor
Institute Hokkaido University Graduate School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019947

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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