UMIN-CTR Clinical Trial

Basic information
Public title	Relationship between nutritional status during hospitalization and prognosis in patients with heart failure.
Acronym	Nutritional status and prognosis in heart failure.
Scientific Title	Relationship between nutritional status during hospitalization and prognosis in patients with heart failure.
Scientific Title:Acronym	Nutritional status and prognosis in heart failure.
Region	Japan

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

Objectives
Narrative objectives1	We investigate the relationship between nutritional status during hospitalization and prognosis in patients with heart failure.
Basic objectives2	Others
Basic objectives -Others	Observational study
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	1.Prognosis 2.CONUT 3.Mini Nutritional Assessment(MNA) 4.Subjective Global Assesment(SGA)
Key secondary outcomes	1.Transthoracic echocardiography 2.Abdominal muscle mass 3.Blood test Prealbumin, Transferrin, Retinol-binding protein, Amino acids fractionation, Homocysteine, Total cholesterol, LDL cholesterol, HDL cholesterol, Triglyceride, Total lymphocyte count, Albumin, Fatty acids profile of lipids, Thyroid stimulating hormone(TSH), Free-Triiodothyronin(F-T3), Free-Thyroxin(F-T4), Hemoglobin A1c, Cystatin C, C-reactive protein(CRP), N-terminal pro-B-type natriuretic peptide(NT-proBNP), Interleukin-6(IL-6), Tumor Necrosis Factor-alpha(TNF-alpha)

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	Hospitalized patients with heart failure.
Key exclusion criteria	Patients who were determined as being ineligible for the study by the investigators or sub investigators.
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Keisuke Middle name Last name Kida
Organization	St. Marianna University School of Medicine
Division name	Division of Cardiology, Department of Internal Medicine
Zip code	2168511
Address	2-16-1 Sugao, Miyamae-ku, Kawasaki city, Kanagawa, Japan
TEL	0449778111
Email	n2suzuki@marianna-u.ac.jp

Public contact
Name of contact person	1st name Norio Middle name Last name Suzuki
Organization	St. Marianna University School of Medicine
Division name	Division of Cardiology, Department of Internal Medicine
Zip code	2168511
Address	2-16-1 Sugao, Miyamae-ku, Kawasaki city, Kanagawa, Japan
TEL	0449778111
Homepage URL
Email	n2suzuki@marianna-u.ac.jp

Sponsor
Institute	St. Marianna University School of Medicine
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	St. Marianna University School of Medicine
Address	2-16-1 Sugao, Miyamae-ku, Kawasaki city, Kanagawa, Japan
Tel	0449778111
Email	k-sienbu.mail@marianna-u.ac.jp

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	2012 Year 09 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	Open public recruiting
Date of protocol fixation	2012 Year 08 Month 24 Day
Date of IRB	2012 Year 06 Month 18 Day
Anticipated trial start date	2012 Year 09 Month 03 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Age, gender, height, body weight, basal heart diseases, medication, complications, frequency of hospitalization, number of days of hospitalization, activities of daily living, vital signs, symptom of heart failure, physical findings, nutritional assessment(CONUT, MNA, SGA), blood test(blood markers), echocardiography, Chest-Xray. * A prospective study.

Management information
Registered date	2012 Year 09 Month 02 Day
Last modified on	2021 Year 09 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010346