UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000023929
Receipt No. R000027321
Scientific Title Prevalence and prognostic value of physical and social frailty in geriatric patients hospitalized for heart failure: A multicenter prospective cohort study
Date of disclosure of the study information 2016/09/05
Last modified on 2017/09/07

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 Open public recruiting
Date of protocol fixation
2016 Year 08 Month 07 Day
Date of IRB
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
2017 Year 09 Month 07 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.