UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032791
Receipt number R000037408
Scientific Title Examination of comorbidity rate, independent predictors, and prognosis of dysphagia in patients with congestive heart failure
Date of disclosure of the study information 2018/05/30
Last modified on 2023/06/02 11:50:59

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Basic information

Public title

Examination of comorbidity rate, independent predictors, and prognosis of dysphagia in patients with congestive heart failure

Acronym

Examination of comorbidity rate, independent predictors, and prognosis of dysphagia in patients with congestive heart failure

Scientific Title

Examination of comorbidity rate, independent predictors, and prognosis of dysphagia in patients with congestive heart failure

Scientific Title:Acronym

Examination of comorbidity rate, independent predictors, and prognosis of dysphagia in patients with congestive heart failure

Region

Japan


Condition

Condition

Congestive heart failure

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify about the actual situation of dysphagia in patients with heart failure.

Basic objectives2

Others

Basic objectives -Others

Aim of present study was to clarify about dysphagia in patients with heart failure; the ratio of comorbidity, prognosis, and prognostic factors.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

the comorbidity rate of dysphagiaon admission

Key secondary outcomes

the improvement rate of dysphagia at discharge

prognosis of dysphagia discharge after 3 month later


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Maneuver

Interventions/Control_1

Evaluation of cgnitive, physical and swallowing function and nutritional status on admission, at discharge and discharged 3 month later

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

the patients who were admitted with acute exacerbation heart failure

Key exclusion criteria

under 20years of age
judged inappropriate by doctor

Target sample size

1500


Research contact person

Name of lead principal investigator

1st name Junichi
Middle name
Last name Yokota

Organization

Tohoku university graduated school of medicine

Division name

Internal medicine and rehabilitation science

Zip code

9808574

Address

1-1, seiryo-chyo, Aoba-ku, sendai, japan

TEL

022-717-7353

Email

jun35230@gmail.com


Public contact

Name of contact person

1st name Junichi
Middle name
Last name Yokota

Organization

Tohoku university graduated school of medicine

Division name

Internal medicine and rehabilitation science

Zip code

9808574

Address

1-1, seiryo-chyo, Aoba-ku, sendai, japan

TEL

022-717-7353

Homepage URL


Email

jun35230@gmail.com


Sponsor or person

Institute

Tohoku 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

National Hospital Organization Sendai Medical Center

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Tohoku university

Address

1-1, seiryo-chyo, Aoba-ku, sendai, japan

Tel

022-717-8007

Email

med-kenkyo@grp.tohoku.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



Other administrative information

Date of disclosure of the study information

2018 Year 05 Month 30 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


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

2015 Year 04 Month 28 Day

Date of IRB

2015 Year 04 Month 29 Day

Anticipated trial start date

2015 Year 04 Month 29 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry

2022 Year 03 Month 31 Day

Date trial data considered complete

2022 Year 03 Month 31 Day

Date analysis concluded

2022 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2018 Year 05 Month 30 Day

Last modified on

2023 Year 06 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037408


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name