UMIN-CTR Clinical Trial

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

Heart failure (HF)

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

Cardiovascular death and readmission due to worsening of HF after discharge

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Tokyo Women's Medical University

Institute

Department

Personal name

Organization

Tokyo Women's Medical University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

12

Month

31

Day

URL releasing protocol

Publication of results

Published

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

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 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).

Registered date

2017

Year

11

Month

25

Day

Last modified on

2017

Year

11

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034389