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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020590
Receipt No. 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

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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
Institute Otsuka Pharmaceutical Co., Ltd.
Institute
Department

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
URL(English) https://upload.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


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