UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000062455
Receipt number	R000071480
Scientific Title	Dietitian-led Multicenter Prospective Registry of Malnutrition in Older Patients with Heart Failure
Date of disclosure of the study information	2026/08/03
Last modified on	2026/08/03 18:31:51

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Basic information

Public title

Dietitian-led Multicenter Prospective Registry of Malnutrition in Older Patients with Heart Failure

Acronym

Dietitian-led Multicenter Prospective Registry of Malnutrition in Older Patients with Heart Failure

Scientific Title

Dietitian-led Multicenter Prospective Registry of Malnutrition in Older Patients with Heart Failure

Scientific Title:Acronym

Dietitian-led Multicenter Prospective Registry of Malnutrition in Older Patients with Heart Failure

Region

Japan

Condition

Heart failure

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

Objectives

Narrative objectives1

This multicenter prospective observational study aims to assess malnutrition at hospital admission and discharge, investigate the provision of nutritional therapy during hospitalization, and examine the associations of these factors with clinical outcomes among older patients with heart failure admitted to acute-care hospitals.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Assessment

Primary outcomes

Composite outcome of all-cause death or readmission within 180 days after hospital discharge

Key secondary outcomes

Composite outcome of all-cause death or readmission within 90 days after hospital discharge
Discharge destination
Length of hospital stay
Physical function at hospital discharge
Hospital-associated disability
Body weight
Appetite

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

65 years-old <=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

(1) Age 65 years or older at hospital admission.
(2) Hospitalization for worsening heart failure accompanied by heart failure symptoms, such as dyspnea at rest or on mild exertion, and signs of congestion, such as peripheral edema, pulmonary crackles, or chest radiographic evidence of pulmonary congestion.
(3) New York Heart Association (NYHA) functional class II to IV.
(4) Natriuretic peptide levels measured from 48 hours before hospital admission to the time of eligibility assessment meeting either of the following thresholds: NT-proBNP of at least 300 pg/mL or BNP of at least 100 pg/mL. For patients with atrial fibrillation, the corresponding thresholds are NT-proBNP of at least 900 pg/mL or BNP of at least 300 pg/mL.

Key exclusion criteria

(1) Initiation of invasive mechanical ventilation within 48 hours after hospital admission.
(2) Admission for diagnostic evaluation or elective surgery.
(3) Maintenance dialysis before hospital admission.
(4) An expected hospital stay of less than 7 days.
(5) A decision to withhold life-sustaining treatment or provision of palliative care.
(6) Previous enrollment in this study.
(7) Unsuitability for participation in this study, as determined by the site principal investigator or a site investigator.

Target sample size

1200

Research contact person

Name of lead principal investigator

1st name Takeshi

Middle name

Last name Saijo

Organization

Osaka Rosai Hospital

Division name

Department of Nutrition Management

Zip code

5918025

Address

1179-3, Nagasone-cho, kita-ku, Sakai, Osaka, Japan

TEL

0722523561

Email

eiyokanrishitsucho@osakah.johas.go.jp

Public contact

Name of contact person

1st name Takeshi

Middle name

Last name Saijo

Organization

Osaka Rosai Hospital

Division name

Department of Nutrition Management

Zip code

5918025

Address

1179-3, Nagasone-cho, kita-ku, Sakai, Osaka, Japan

TEL

0722523561

Homepage URL

Email

eiyokanrishitsucho@osakah.johas.go.jp

Sponsor or person

Institute

Other

Institute

Department

Personal name

Takeshi Saijo

Funding Source

Organization

None

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

Ethics Committee of Osaka Rosai Hospital

Address

1179-3, Nagasone-cho, kita-ku, Sakai, Osaka, Japan

Tel

0722523561

Email

soumukatyou@osakah.johas.go.jp

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

独立行政法人労働者健康安全機構大阪労災病院（大阪府）
社会医療法人近森会近森病院（高知県）
医療法人名古屋澄心会名古屋ハートセンター（愛知県）
国家公務員共済組合連合会呉共済病院（広島県）
聖マリアンナ医科大学病院（神奈川県）
国家公務員共済組合連合会大手前病院（大阪府）
国家公務員共済組合連合会枚方公済病院　（大阪府）
医療法人社団愛友会上尾中央総合病院（埼玉県）　
社会医療法人仙養会北摂総合病院（大阪府）
済生会横浜市東部病院（神奈川県）
りんくう総合医療センター（大阪府）
日本赤十字社武蔵野赤十字病院（東京都）
日本赤十字社愛知医療センター名古屋第一病院（愛知県）
JA愛知厚生連豊田厚生病院（愛知県）
豊川市民病院（愛知県）
近畿大学病院（大阪府）　
国立研究開発法人国立長寿医療研究センター（愛知県）
JA愛知厚生連安城更生病院（愛知県）
独立行政法人労働者健康安全機構中部労災病院（愛知県）
一宮市立市民病院（愛知県）
トヨタ記念病院（愛知県）
一般財団法人竹田健康財団竹田綜合病院（福島県）
国家公務員共済組合連合会横浜栄共済病院（神奈川県）
広島大学附属病院（広島県）
JA広島厚生連 JA尾道総合病院（広島県）
聖マリアンナ医科大学横浜市西部病院（神奈川県）
国家公務員共済組合連合会虎の門病院（東京都）

Other administrative information

Date of disclosure of the study information

2026 Year 08 Month 03 Day

Related information

URL releasing protocol

Publication of results

Unpublished

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

Preinitiation

Date of protocol fixation

2026 Year 07 Month 29 Day

Date of IRB

2026 Year 07 Month 29 Day

Anticipated trial start date

2026 Year 10 Month 01 Day

Last follow-up date

2033 Year 09 Month 30 Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

Other related information

None

Management information

Registered date

2026 Year 08 Month 03 Day

Last modified on

2026 Year 08 Month 03 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071480