UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028034
Receipt number R000032098
Scientific Title Evaluation of severity of heart failure using non-invasive monitoring system with conactless sheet sensor
Date of disclosure of the study information 2017/07/05
Last modified on 2020/12/02 13:57:11

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Basic information

Public title

Evaluation of severity of heart failure using non-invasive monitoring system with conactless sheet sensor

Acronym

Evaluation of severity of heart failure using non-invasive monitoring system with conactless sheet sensor

Scientific Title

Evaluation of severity of heart failure using non-invasive monitoring system with conactless sheet sensor

Scientific Title:Acronym

Evaluation of severity of heart failure using non-invasive monitoring system with conactless sheet sensor

Region

Japan


Condition

Condition

chronic heart failure

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We evaluate relationship among the nocturnal respiratory stability obtained by contactless sheet sensor system and standard markers of heart failure to confrim the hypothesis that nocturnal respiratory stability is correlated with severity of heart failure

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The correlation among nocturnal respiratory stability and standard markers of heart failure

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

chronic heart failure patients
hospitalized patients

Key exclusion criteria

underaged patients

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshiki Sawa

Organization

Osaka University

Division name

Department of Cardiovascular Surgery

Zip code


Address

2-2 Yamadaoka, Suita City, Osaka, Japan

TEL

81-6-6879-3154

Email

k-domae@surg1.med.osaka-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Keitaro Domae

Organization

Osaka University

Division name

Department of Cardiovascular Surgery

Zip code


Address

2-2 Yamadaoka, Suita City, Osaka, Japan

TEL

81-6-6879-3154

Homepage URL

http://www2.med.osaka-u.ac.jp/surg1/research/clinical-research/

Email

k-domae@surg1.med.osaka-u.ac.jp


Sponsor or person

Institute

Department of Cardiovascular Surgery, Osaka University

Institute

Department

Personal name



Funding Source

Organization

none

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


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

大阪大学付属病院


Other administrative information

Date of disclosure of the study information

2017 Year 07 Month 05 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

Completed

Date of protocol fixation

2017 Year 06 Month 20 Day

Date of IRB

2017 Year 06 Month 29 Day

Anticipated trial start date

2017 Year 07 Month 01 Day

Last follow-up date

2020 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

none


Management information

Registered date

2017 Year 07 Month 01 Day

Last modified on

2020 Year 12 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032098


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name