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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030119
Receipt No. R000034389
Scientific Title Nutritional status at discharge is associated with long-term prognosis in patients with acute heart failure
Date of disclosure of the study information 2017/12/31
Last modified on 2017/11/27

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Basic information
Public title Nutritional status at discharge is associated with long-term prognosis in patients with acute heart failure
Acronym Nutritional status at discharge and long-term prognosis in HF patients
Scientific Title Nutritional status at discharge is associated with long-term prognosis in patients with acute heart failure
Scientific Title:Acronym Nutritional status at discharge and long-term prognosis in HF patients
Region
Japan

Condition
Condition Heart failure (HF)
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of present study is to investigate the association of CONUT score at the time of discharge from hospital with outcomes in patients who were discharged alive after hospitalizaion for acute decompensated HF.
Basic objectives2 Others
Basic objectives -Others Nutritional status on admission is an independent predictor of mortality in patients with heart failure.CONUT(controlling nutritional status)score well represents nutritional status in patients.There has been limited evidence about the relationship between CONUT score at discharge and long-term prognosis in patients with acute HF. This study investigated that theme.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Cardiovascular death and readmission due to worsening of HF after discharge
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who were urgently hospitalized for acute decompensation of chronic HF or acute HF in a single cardiovascular center between July 2013 and February 2016. Patients were diagnosed with HF using the Framingham diagnostic criteria.
Key exclusion criteria Patients who were receiving regular hemodialysis and died in hospital.
Target sample size 365

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuhisa Hagiwara
Organization Tokyo Women's Medical University
Division name Department of Cardiology
Zip code
Address 8-1 Kawatacho, Shinjyuku-ku, Tokyo, Japan,162-8666
TEL 0333538111
Email juken1123@mac.com

Public contact
Name of contact person
1st name
Middle name
Last name Kentaro Jujo
Organization Tokyo Women's Medical University
Division name Department of Cardiology
Zip code
Address 8-1 Kawatacho, Shinjyuku-ku, Tokyo, Japan,162-8666
TEL 0333538111
Homepage URL
Email juken1123@mac.com

Sponsor
Institute Tokyo Women's Medical University
Institute
Department

Funding Source
Organization Tokyo Women's Medical University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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
2017 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results 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
2013 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The present study initially included 444 consecutive patients who were urgently hospitalized for acute decompensation of chronic HF or acute HF in a single cardiovascular center between July 2013 and February 2016. Patients were diagnosed with HF using the Framingham HF diagnostic criteria. After the exclusion of 41 patients who were receiving regular hemodialysis and 38 patients who died in hospital, total of 365 patients were divided into 2 groups depending on CONUT score at admission or at discharge with cut-off of 3 point, referring to previous reports. We compared clinical profiles, medications, in-hospital and long-term prognosis among groups. The primary endpoint of this study was a composite of CV death post discharge and readmission due to decompensation of HF. Patients with baseline high CONUT score showed significantly higher in-hospital CV death than those with lower score (10.1% vs. 2.9%, p = 0.005).However, among patients who discharge alive from hospital, baseline CONUT score did not make significant difference in the primary endpoint (Log-rank test: p = 0.07). In contrast, patients with high CONUT score at discharge had a significantly higher rate of the primary outcome than those with low CONUT score at discharge (p < 0.001).

Management information
Registered date
2017 Year 11 Month 25 Day
Last modified on
2017 Year 11 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034389

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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