UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023929 |
|---|---|
| Receipt number | 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 | 2020/09/08 10:16:14 |
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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
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
kgnb_27_hot@yahoo.co.jp
Sponsor or person
Institute
Department of Cardiology, The Sakakibara Heart Institute of Okayama
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027321
