UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035157
Receipt number R000040071
Scientific Title Prospective Observational study on acute PharmacothErapY and prognosis in managEment of Acute Heart Failure
Date of disclosure of the study information 2018/12/10
Last modified on 2020/12/17 15:57:00

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Basic information

Public title

Prospective Observational study on acute PharmacothErapY and prognosis in managEment of Acute Heart Failure

Acronym

Prospective Observational study on acute PharmacothErapY and prognosis in managEment of Acute Heart Failure

Scientific Title

Prospective Observational study on acute PharmacothErapY and prognosis in managEment of Acute Heart Failure

Scientific Title:Acronym

Prospective Observational study on acute PharmacothErapY and prognosis in managEment of Acute Heart Failure

Region

Japan


Condition

Condition

Acute heart failure

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Survey on actual condition of therapy in acute heart failure, and outcome.

Basic objectives2

Others

Basic objectives -Others

Event (hospitalization, cardiac death, all-cause mortality)

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Event (hospitalization, cardiac death, all-cause mortality)

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

200 years-old >

Gender

Male and Female

Key inclusion criteria

Acute heart failure hospitalization

Key exclusion criteria

Acute coronary syndrome
Dialysis
After herat transplant

Target sample size

1500


Research contact person

Name of lead principal investigator

1st name Toyoaki
Middle name
Last name Murohara

Organization

Nagoya university Graduate school of medicine

Division name

Cardiology

Zip code

466-8550

Address

65 Turumai-cyo Syowa-ku, Nagoya, Aichi, Japan

TEL

052-741-2111

Email

takaoku@med.nagoya-u.ac.jp


Public contact

Name of contact person

1st name Tasuku
Middle name
Last name Kuwayama

Organization

Nagoya university Graduate school of medicine

Division name

Cardiology

Zip code

466-8550

Address

65 Turumai-cyo Syowa-ku, Nagoya, Aichi, Japan

TEL

052-741-2111

Homepage URL


Email

tkuwayama@med.nagoya-u.ac.jp


Sponsor or person

Institute

Nagoya university Graduate school of medicine

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

IRB

Address

65 Turumai-cyo Syowa-ku, Nagoya, Aichi, Japan

Tel

052-744-2973

Email

ethics@med.nagoya-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



Other administrative information

Date of disclosure of the study information

2018 Year 12 Month 10 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

Open public recruiting

Date of protocol fixation

2018 Year 11 Month 12 Day

Date of IRB

2018 Year 10 Month 24 Day

Anticipated trial start date

2018 Year 11 Month 12 Day

Last follow-up date

2022 Year 01 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

2018 Year 12 Month 06 Day

Last modified on

2020 Year 12 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040071


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name