UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021917
Receipt number R000025040
Scientific Title Development of new weight scales for heart failure patients
Date of disclosure of the study information 2016/04/15
Last modified on 2023/04/21 10:17:38

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Basic information

Public title

Development of new weight scales for heart failure patients

Acronym

Development of new weight scales for heart failure patients

Scientific Title

Development of new weight scales for heart failure patients

Scientific Title:Acronym

Development of new weight scales for heart failure patients

Region

Japan


Condition

Condition

Heart failure

Classification by specialty

Medicine in general Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To develop new weight scales for heart failure patients

Basic objectives2

Others

Basic objectives -Others

To develop new weight scales for heart failure patients and evaluate its efficacy

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

To evaluate efficacy of new weight scales in terms of detecting heart failure conditions

Key secondary outcomes

None


Base

Study type

Others,meta-analysis etc


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

Heart failure patients

Key exclusion criteria

Patients with cardiac devices (permanent pacemaker, ICD, CRT and CRT-D)

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Hiroaki
Middle name
Last name Kitaoka

Organization

Kochi Medical School, Kochi University

Division name

Department of Cardiology and Geriatrics

Zip code

783-8505

Address

Kohasu, Nankoku-chi, Kochi-ken, JAPAN

TEL

088-880-2352

Email

kitaokah@kochi-u.ac.jp


Public contact

Name of contact person

1st name Minaguchi, Tabuchi
Middle name
Last name Minaguchi, Tabuchi

Organization

Kochi Medical School Hospital

Division name

Kochi Medical School Hospital

Zip code

783-8505

Address

Kohasu, Nankoku-chi, Kochi-ken, JAPAN

TEL

088-880-2352

Homepage URL

http://www.kochi-ms.ac.jp/html/gakubu/fm_gratr.html

Email

rinri21@kochi-u.ac.jp


Sponsor or person

Institute

Kochi Medical School, Kochi University

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

None


Other related organizations

Co-sponsor

OMRON HEALTHCARE Co., Ltd

Name of secondary funder(s)

None


IRB Contact (For public release)

Organization

Kochi Medical School Hospital

Address

Kochi Medical School Hospital

Tel

088-880-2797

Email

rinri21@kochi-u.ac.jp


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

高知大学医学部附属病院(Kochi Medical School Hospital)


Other administrative information

Date of disclosure of the study information

2016 Year 04 Month 15 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

Enrolling by invitation

Date of protocol fixation

2015 Year 08 Month 04 Day

Date of IRB

2015 Year 08 Month 04 Day

Anticipated trial start date

2016 Year 04 Month 18 Day

Last follow-up date

2024 Year 03 Month 31 Day

Date of closure to data entry

2024 Year 03 Month 31 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information

Enrolling by invitation


Management information

Registered date

2016 Year 04 Month 15 Day

Last modified on

2023 Year 04 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025040


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name