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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031635
Receipt No. R000035365
Scientific Title Comparison of various methods in evaluation of sarcopenia in patients with heart failure: A multicenter prospective observational study
Date of disclosure of the study information 2018/03/08
Last modified on 2018/05/04

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Basic information
Public title Comparison of various methods in evaluation of sarcopenia in patients with heart failure: A multicenter prospective observational study
Acronym Comparison of various methods in evaluation of sarcopenia in patients with heart failure (SONIC-HF)
Scientific Title Comparison of various methods in evaluation of sarcopenia in patients with heart failure: A multicenter prospective observational study
Scientific Title:Acronym Comparison of various methods in evaluation of sarcopenia in patients with heart failure (SONIC-HF)
Region
Japan

Condition
Condition Heart Failure
Classification by specialty
Cardiology Geriatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective of this study is to investigate the difference in prognostic impact of measuring muscle mass and function using ultrasound as well as anthropometric measurements.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes All-cause mortality
Key secondary outcomes Unexpected visit to the hospital, readmission due to heart failure, all-cause readmission.
Physical and functional status at baseline.

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 The patients who were admitted to each hospital due to heart failure
(1) The diagnosis of heart failure is based on the Framingham criteria, which is stated in the guideline of Japanese Circulation Society (http://www.j-circ.or.jp/guideline/pdf/JCS2011_izumi_h.pdf ; last accessed August 7th, 2016).
(2) The patients older than 64 years old are eligible
(3) The patients who can walk by themselves (including the patients who can walk using a staff and so on) are eligible (who suffered in-hospital death will be excluded)
Key exclusion criteria (1) The patients with low serum BNP (<100pg/ml) / NT-pro BNP (<300pg/ml) level on admission
(2) The hemodialysis patients (including the patients planning to start hemodialysis)
(3) The patients planning to undergo surgery for valvular heart disease or similar surgery
(4) The patients who had undergone heart transplantation or the patients with ventricular assist devices
(5) The patients with acute myocarditis
(6) The patients who refused to participate in the study
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Emi Maekawa / Nobuyuki Kagiyama
Organization Kitasato University School of Medicine / Tokyo Medical and Dental University
Division name Department of Cardiovascular Medicine / Department of Cardiovascular Medicine
Zip code
Address 1-15-1 Kitasato, Sagamihara, Kanagawa, Japan
TEL 042-778-8111
Email emimae1207@med.kitasato-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Emi Maekawa / Nobuyuki Kagiyama
Organization Kitasato University School of Medicine / Tokyo Medical and Dental University
Division name Department of Cardiovascular Medicine / Department of Cardiovascular Medicine
Zip code
Address 1-15-1 Kitasato, Sagamihara, Kanagawa, Japan
TEL 042-778-8111
Homepage URL
Email emimae1207@med.kitasato-u.ac.jp

Sponsor
Institute Department of Cardiovascular Medicine, Kitasato University School of Medicine
Institute
Department

Funding Source
Organization self-funded
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
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 B17-210
Org. issuing International ID_1 Kitasato University School of Medicine
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 北里大学病院、心臓病センター榊原病院、亀田総合病院、神戸市立医療センター中央市民病院

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 08 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
2018 Year 01 Month 17 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 08 Day
Last follow-up date
2021 Year 12 Month 31 Day
Date of closure to data entry
2022 Year 12 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information This multi-center registry study will include geriatric patients with heart failure. In addition to the patient characteristics and results of clinically indicated tests, the following tests will be performed: The assessment of muscle mass and function using ultrasound, physical function tests, etc. Frailty factors will be also evaluated as important confounders. Predictors for all-cause death will be investigated.

Management information
Registered date
2018 Year 03 Month 08 Day
Last modified on
2018 Year 05 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035365

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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