UMIN-CTR Clinical Trial

Basic information
Public title	Prevalence and prognostic value of physical and social frailty in geriatric patients hospitalized for heart failure: A multicenter prospective cohort study
Acronym	FRAGILE-HF
Scientific Title	Prevalence and prognostic value of physical and social frailty in geriatric patients hospitalized for heart failure: A multicenter prospective cohort study
Scientific Title:Acronym	FRAGILE-HF
Region	Japan

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

Objectives
Narrative objectives1	Although physical and social frailties have been supposed to be associated with poorer prognosis in cardiovascular disease, there has been no study elucidating these association with heart failure comprehensively with sufficient sample size. The aim of this study is, therefore, to determine the prevalence of physical and social frailty among the elderly patients with heart failure and their impact on the prognosis.
Basic objectives2	Others
Basic objectives -Others	Exploratory cohort study
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
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, and so on.

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	To determine the prevalence of the physical and social frailty among the patients with heart failure and their impact on the prognosis 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	1200

Research contact person
Name of lead principal investigator	1st name Middle name Last name Nobuyuki Kagiyama / Yuya Matsue
Organization	The Sakakibara Heart Institute of Okayama / University of Groningen
Division name	Department of Cardiology / Department of Cardiology
Zip code
Address	2-5-1 Nakaicho, Kitaku, Okayama, Japan / Hanzeplein 1, 9713 GZ, Groningen, The Netherlands
TEL	086-225-7111
Email	kgnb_27_hot@yahoo.co.jp

Public contact
Name of contact person	1st name Middle name Last name Nobuyuki Kagiyama / Yuya Matsue
Organization	The Sakakibara Heart Institute of Okayama / University of Groningen
Division name	Department of Cardiology / Department of Cardiology
Zip code
Address	2-5-1 Nakaicho, Kitaku, Okayama, Japan / Hanzeplein 1, 9713 GZ, Groningen, The Netherlands
TEL	086-225-7111
Homepage URL
Email	kgnb_27_hot@yahoo.co.jp

Sponsor
Institute	Department of Cardiology, The Sakakibara Heart Institute of Okayama
Institute
Department

Funding Source
Organization	No funding
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Kameda Medical Center, Kitasato University Hospital, Kobe City Medical Center General Hospital, Nishiarai Heart Center Hospital, Juntendo University Hospital, Kitasato University Medical Center, Mitsui Memorial Hospital, Yokohama City University Medical Center, Tokai University Hospital, Shishu University Hospital, Saitama medical Center Jichi Medical University, Odawara City Hospital, and others
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	心臓病センター榊原病院、亀田総合病院、北里大学病院、神戸市立医療センター中央市民病院、西新井ハートセンター病院、順天堂大学付属順天堂医院、北里大学メディカルセンター、三井記念病院、横浜市立大学付属市民総合医療センター、東海大学医学部付属病院、信州大学医学部付属病院、自治医科大学付属さいたま医療センター、小田原市立病院、春日部中央総合病院、さいたま市民医療センター

Other administrative information
Date of disclosure of the study information	2016 Year 09 Month 05 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	Main results already published
Date of protocol fixation	2016 Year 08 Month 07 Day
Date of IRB	2016 Year 08 Month 31 Day
Anticipated trial start date	2016 Year 09 Month 05 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry	2021 Year 12 Month 31 Day
Date trial data considered complete	2022 Year 12 Month 31 Day
Date analysis concluded	2024 Year 12 Month 31 Day

Other

Other related information

Design Multicenter prospective cohort study Patient selection Patients who met the inclusion criteria and do not conflict with the exclusion criteria. (These criteria are stated above) Observation Laboratory tests and the other backgroud information Physical frailty test, including grip strength, gait speed, boundary length of upper and lower arm, skeletal muscle mass measured by DEXA and/or bio-impedance method, sarcopenia evaluated by SARC-F score, Fried criteria, Frailty score, FRAIL-scale, body weight change, appetite, fatigue, lean body weight and so on Social frailty test, including modified Lubben Social Network Scale (LSNS-6), social frail score by Makisako and other criteria.

Management information
Registered date	2016 Year 09 Month 05 Day
Last modified on	2020 Year 09 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027321