UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000000736
Receipt number R000000884
Scientific Title Acute Decompensated Heart Failure Syndromes Registry in Japan Multicenter prospective observational cohort study
Date of disclosure of the study information 2007/06/12
Last modified on 2014/06/08 10:18:31

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Basic information

Public title

Acute Decompensated Heart Failure Syndromes Registry in Japan
Multicenter prospective observational cohort study

Acronym

ATTEND registry

Scientific Title

Acute Decompensated Heart Failure Syndromes Registry in Japan
Multicenter prospective observational cohort study

Scientific Title:Acronym

ATTEND registry

Region

Japan


Condition

Condition

Acute decompensated heart failure syndromes

Classification by specialty

Medicine in general Cardiology Emergency medicine
Intensive care medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate characteristics, clinical features, management of acute decompensated heart failure in Japan

Basic objectives2

Others

Basic objectives -Others

To clarify as follows;
1. patient characteristics and clinical features
2. states of management
3. in-hospital death and outcome during 180 days after admission

Trial characteristics_1


Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

1. diagnosis, patient characteritics, physical findings, blood chemistry
2.re-admission rate and outcome in-hospital, 30 days, and 180 days after admission

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

Diagnosed patients by Framingham's criteria

Key exclusion criteria

1.less than 20 year old and unmarried
2.acute coronary syndrome
3. inappropriated patient by the judgement of the doctor

Target sample size

10000


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Teruo Takano

Organization

Nippon Medical School

Division name

Division of cardiology, Department of Internal medicine

Zip code


Address

1-1-5 Sendagi Bunkyo-ku, Tokyo, Japan

TEL

03-3822-2131

Email

takanot@nms.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Naoki Sato

Organization

ATTEND office

Division name

Cardiology and Intensive Care Unit, Nippon Medical School Musashi-Kosugi Hospital

Zip code


Address

1-396 Kosugi-cho Nakahara-ku Kawasaki-shi, Kanagawa

TEL

03-3822-2131

Homepage URL

http://www.j-attend.jp/

Email

nms-ns@nms.ac.jp


Sponsor or person

Institute

ATTEND registry committee

Institute

Department

Personal name



Funding Source

Organization

Japan Heart Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan


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

2007 Year 06 Month 12 Day


Related information

URL releasing protocol

https://www.statz.jp/AhF200605/Main_Menu.php

Publication of results

Partially published


Result

URL related to results and publications

http://www.j-attend.jp/

Number of participants that the trial has enrolled


Results

1. Am Heart J 159:949-955,2010
2. Int J Cardiol 153:102-1051,2011
3. J Am Coll Cardiol 61:820-829, 2013
4. Am J Cardiol 111:1019-1025.2013.
5. Int J Cardiol 168:2186-2194, 2013.
6. Int J Cardiol 168:554-556,2013.
7. Circ J 77:944-951, 2013.
8. Int J Cardiol 168:4790-4795, 2013.
9. Int J Cardiol 172:165-72, 2014.
10. Int J Cardiol. 171:98-100, 2014.
11. J Am Coll Cardiol. 63:1123-1133,2014.

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

No longer recruiting

Date of protocol fixation

2007 Year 04 Month 01 Day

Date of IRB


Anticipated trial start date

2007 Year 04 Month 01 Day

Last follow-up date

2012 Year 12 Month 31 Day

Date of closure to data entry

2013 Year 04 Month 01 Day

Date trial data considered complete

2013 Year 06 Month 30 Day

Date analysis concluded

2015 Year 12 Month 31 Day


Other

Other related information

gender, age, body height and weight
patient characteristics(heart failure, arrhythmia, respiratory, device, cerebral infarction, pulmonary diasease, hypertension, dyslipidemia, diabetes mellitus, smoking)
physical findings(symptoms, vital signs)
examination(electrocardiogram, blood chemistry, ultrasound)
management (intravenous and oral agents, respiration, device)
outcome


Management information

Registered date

2007 Year 06 Month 08 Day

Last modified on

2014 Year 06 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000884


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name