UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020590
Receipt number R000023767
Scientific Title Survey on the actual situation of treatment in heart failure on admission: A multicenter, use of electronic medical records and claims data, pharmaco-epidemiology, cohort study.(RECOMEND study)
Date of disclosure of the study information 2016/02/01
Last modified on 2019/12/02 20:04:14

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Basic information

Public title

Survey on the actual situation of treatment in heart failure on admission: A multicenter, use of electronic medical records and claims data, pharmaco-epidemiology, cohort study.(RECOMEND study)

Acronym

Survey on the actual situation of treatment in heart failure on admission: A multicenter, use of electronic medical records and claims data, pharmaco-epidemiology, cohort study.(RECOMEND study)

Scientific Title

Survey on the actual situation of treatment in heart failure on admission: A multicenter, use of electronic medical records and claims data, pharmaco-epidemiology, cohort study.(RECOMEND study)

Scientific Title:Acronym

Survey on the actual situation of treatment in heart failure on admission: A multicenter, use of electronic medical records and claims data, pharmaco-epidemiology, cohort study.(RECOMEND study)

Region

Japan


Condition

Condition

Heart failure

Classification by specialty

Cardiology Cardiovascular surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To characterize the treatment of congestive heart failure patients on acute admission and to determine the association between the quality of medical care and clinical outcomes.

Basic objectives2

Others

Basic objectives -Others

Pharmaco-epidemiology

Trial characteristics_1

Exploratory

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

1. Hospitalization length
2. In-hospital death

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

Target Population
Patients who were hospitalized for heart failure in acute care hospitals between January 2010 to December 2015.

Inclusion Criteria
Patients who meet any of the following criteria during any hospitalization will be included.

1) Hospitalization cases due to heart failure (ICD-10: I50) based on any of the following data elements:
a) "Diagnosis that triggered hospitalization"
b) "Diagnosis with highest medical cost"
c) "Main Diagnosis decided by the physician based on medical judgment"

2) Hospitalization cases in which the "Diagnosis with highest medical cost" could be included in any of the following classifications: a) Any diagnosis included in the ICD-10 code list below; b) Patients who received one or more of the listed agents during hospitalization.

a) Diagnosis (ICD-10):
I21$, I22$, I23$, I24$, I510, I20$, I25$, I420, I421, I422, I423, I424, I425, I426, I427, I428, I429, I43$, I515, I456, I47$, I48, I490, I491, I492, I493, I494, I498, I05$, I06$, I07$, I08$, I34$, I35$, I36$, I37$, I33$, I38, I40$, I41$, I514, I010, I018, I30$, I318, I32$, I310, I311, I50$, I110, I130, I132.
$: The numbers from "0" to "9".

b) Intravenous Agents:
Digoxin, Deslanoside, Amiodarone Hydrochloride, l-Isoprenaline Hydrochloride, Etilefrine Hydrochloride, Noradrenaline, Phenylephrine Hydrochloride,Dopamine Hydrochloride, Dobutamine Hydrochloride, Dipyridamole, Nicorandil, Nitroglycerin, Isosorbide Dinitrate, Olprinone Hydrochloride Hydra, Milrinone, Carperitide, Potassium Canrenoate, Piretanide, Bumetanide, Furosemide, Landiolol Hydrochloride, Diltiazem Hydrochloride, Nicardipine Hydrocloride, Verapamil Hydrochloride.
Oral Agents:
Eplerenone, Spironolacton, Azosemide, Torasemide, Piretanide, Bumetanide, Furosemide, Indapamide, Trichlormethiazide, Hydrochlorothiazide, Tolvaptan.

Key exclusion criteria

Age < 20 years old (on admission)

Target sample size

5000


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Koichi Nakao, Takeo Nakayama

Organization

Saiseikai Kumamoto Hospital,
Kyoto University School of Public Health

Division name

Cardiology, Department of Health Informatics

Zip code


Address

5-3-1 Chikami, Minami-ku, Kumamoto-city,861-4193 Japan, Yoshida-Konoe, Sakyo-ku, Kyoto, Kyoto, 606-8501, Japan.

TEL

(096-351-8000)(075-753-4488)

Email

koichi-nakao@saiseikaikumamoto.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hiromichi Chikashima

Organization

Otsuka Pharmaceutical Co., Ltd.

Division name

Medical Affairs

Zip code


Address

Shinagawa Grand Central Tower, 2-16-4 Konan, Minato-ku, Tokyo 108-8242, Japan

TEL

03-6717-1400

Homepage URL


Email

Recomend_study@otsuka.jp


Sponsor or person

Institute

Otsuka Pharmaceutical Co., Ltd.

Institute

Department

Personal name



Funding Source

Organization

Otsuka Pharmaceutical Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

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

済生会横浜市東部病院(神奈川県),福岡県済生会福岡総合病院(福岡県),済生会熊本病院(熊本県)


Other administrative information

Date of disclosure of the study information

2016 Year 02 Month 01 Day


Related information

URL releasing protocol

https://doi.org/10.1253/circrep.CR-19-0051

Publication of results

Published


Result

URL related to results and publications

https://doi.org/10.1253/circrep.CR-19-0051

Number of participants that the trial has enrolled

3864

Results

Results: Factors contributing to in-hospital death were advanced age, higher New York Heart Association (NYHA) class, low albumin and sodium, and high creatinine and C-reactive protein (CRP). Factors contributing to prolonged hospitalization were higher NYHA class, low Barthel index, low albumin, and high B-type natriuretic peptide, lactate dehydrogenase, and CRP.

Conclusions: This approach may be helpful to address clinical parameters of HF patients in any acute care hospital in Japan.

Results date posted

2019 Year 12 Month 02 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2019 Year 11 Month 22 Day

Baseline Characteristics

Mean age was 77.0 (SD 13.0)years; 55.3% (n=1,520) were men, and 39.1% (n=759) had left ventricular ejection fraction <40%. In-hospital mortality was 6.0% (n=164) and mean length of stay for patients who were discharged alive was 18.2 (SD 13.7) days (median, 15 days).

Participant flow

Article ID: CR-19-0051
Published: November 22, 2019
[Advance publication] Released: November 22, 2019
DOI: https://doi.org/10.1253/circrep.CR-19-0051

Supplementary Files
https://www.jstage.jst.go.jp/article/circrep/advpub/0/advpub_CR-19-0051/_supplement/_download/advpub_CR-19-0051_1.pdf

Adverse events

Not applicable

Outcome measures

Results: Factors contributing to in-hospital death were advanced age, higher New York Heart Association (NYHA) class, low albumin and sodium, and high creatinine and C-reactive protein (CRP). Factors contributing to prolonged hospitalization were higher NYHA class, low Barthel index, low albumin, and high B-type natriuretic peptide, lactate dehydrogenase, and CRP.

Conclusions: This approach may be helpful to address clinical parameters of HF patients in any acute care hospital in Japan.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2015 Year 12 Month 18 Day

Date of IRB

2016 Year 02 Month 08 Day

Anticipated trial start date

2016 Year 11 Month 01 Day

Last follow-up date

2017 Year 05 Month 19 Day

Date of closure to data entry


Date trial data considered complete

2017 Year 05 Month 19 Day

Date analysis concluded

2019 Year 02 Month 12 Day


Other

Other related information

Retrospective cohort study


Management information

Registered date

2016 Year 01 Month 15 Day

Last modified on

2019 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=R000023767


Research Plan
Registered date File name
2016/07/15 156_104_00053_SAP_V100_20160202.pdf

Research case data specifications
Registered date File name

Research case data
Registered date File name