UMIN-CTR Clinical Trial

Basic information
Public title	Prognostic value of sarcopenia on mortality in patients with cardiovascular disease
Acronym	Prognostic value of sarcopenia on mortality in patients with cardiovascular disease
Scientific Title	Prognostic value of sarcopenia on mortality in patients with cardiovascular disease
Scientific Title:Acronym	Prognostic value of sarcopenia on mortality in patients with cardiovascular disease
Region	Japan

Condition
Condition	Patients with cardiovascular disease including congestive heart failure and acute myocardial infarction
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate prognostic value of skeletal muscle dysfunction in patients with cardiovascular disease
Basic objectives2	Others
Basic objectives -Others	Evaluation of skeletal muscle dysfunction
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	All-cause mortality
Key secondary outcomes	In-hospital mortality Cardiovascular death Heart Failure rehospitalization Acute kidney injury/worsening renal function Urine output during hospitalization Skeletal muscle mass Brain-derived neurotrophic factor (BDNF) Gait speed Grip strength Maximal oxygen consumption Bioelectrical Impedance analysis (BIA)

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	60 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients hospitalizaed with acute heart failure or acute myocardial infarction
Key exclusion criteria	1)Patients with out-of-hospital cardiac arrest 2)Patients with malignant disease with life expectancy within 1 year 3)Patinets with no obtained informed concent
Target sample size	500

Research contact person
Name of lead principal investigator	1st name Koichiro Middle name Last name Matsumura
Organization	Kindai University
Division name	Department of Cardiology
Zip code	5898511
Address	377-2, Ohnohigashi, Osakasayama
TEL	+81723660221
Email	kmatsumura1980@yahoo.co.jp

Public contact
Name of contact person	1st name Koichiro Middle name Last name Matsumura
Organization	Kindai University
Division name	Department of Cardiology
Zip code	5898511
Address	377-2, Ohnohigashi, Osakasayama
TEL	+81723660221
Homepage URL
Email	kmatsumura1980@yahoo.co.jp

Sponsor
Institute	Kindai University
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Department of Cardiology, Kindai University
Address	377-2, Ohnohigashi, Osaasayama
Tel	+8172366-0221
Email	kmatsumura1980@yahoo.co.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	枚方公済病院（大阪）

Other administrative information
Date of disclosure of the study information	2019 Year 12 Month 17 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	Terminated
Date of protocol fixation	2019 Year 10 Month 08 Day
Date of IRB	2019 Year 10 Month 08 Day
Anticipated trial start date	2019 Year 10 Month 08 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2021 Year 03 Month 31 Day

Other
Other related information	Evaluation of treatment detail during hospitalization and subsequent long-term outcome

Management information
Registered date	2019 Year 12 Month 17 Day
Last modified on	2021 Year 04 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044366