UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043959 |
|---|---|
| Receipt number | R000050207 |
| Scientific Title | Prevalence and prognostic implication of sarcopenia among patients with stage B heart failure |
| Date of disclosure of the study information | 2021/06/01 |
| Last modified on | 2021/11/05 16:23:43 |
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Basic information
Public title
Prevalence and prognostic implication of sarcopenia among patients with stage B heart failure
Acronym
PAPRIKA-HF
Scientific Title
Prevalence and prognostic implication of sarcopenia among patients with stage B heart failure
Scientific Title:Acronym
PAPRIKA-HF
Region
| Japan |
Condition
Condition
Heart failure
Classification by specialty
| Cardiology | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate prevalence of sarcopenia and relationship between sarcopenia and prognosis in patients with stage B heart failure
Basic objectives2
Others
Basic objectives -Others
Exploratory cohort study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Composite endpoint including all-cause death, hospitalization due to acute coronary syndrome or heart failure hospitalization
Key secondary outcomes
All-cause death
Hospitalization due to acute coronary syndrome
Heart failure hospitalization
Prevalence of sarcopenia
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
Outpatients received with echocardiography
The participants who can walk by themselves (including the participants who can walk using a staff and so on)
Key exclusion criteria
The participants who refused to participate in the study
Participants treated with permanent pacemaker implantation
Participants with hemodialysis
Participants with active malignant disease
Participants underwent heart transplantation or those treated with ventricular assist device
Target sample size
600
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
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
kmatsumura1980@yahoo.co.jp
Sponsor or person
Institute
Kindai University
Institute
Department
Personal name
Funding Source
Organization
No funding
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
Department of Cardiology, Kindai University
Address
377-2, Ohnohigashi, Osakasayama
Tel
09011701140
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
関西医科大学附属病院（大阪府）、枚方公済病院（大阪府）、もりした循環器科クリニック（京都府）、有田市立病院（和歌山県）、東海大学医学部付属病院（神奈川県）、東邦大学医療センター大森病院（東京都）、聖マリアンナ医科大学（神奈川県）、帝京大学医学部附属病院(東京都)
Kansai Medical University Hospital, Hirakata Kohsai Hospital, Morishita Heart Clinic, Arita City Hospital, Tokai University School of Medicine, Toho University Faculty of Medicine, St. Marianna University School of Medicine, Teikyo University Hospital
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 06 | Month | 01 | 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
| 2021 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 13 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Design:
Multicenter prospective cohort study
Participants:
65 years or over outpatients with stage B heart failure
Definition of stage B heart failure:
Participants without history of heart failure hospitalization who have past medical history including old myocardial infarction, atrial fibrillation, moderate or severe aortic/mitral valvular disease, previous aortic/mitral valvular surgery, or cardiac abnormality according to ARIC definition
Participant selection:
Participants who met the inclusion criteria and do not conflict with the exclusion criteria (These criteria are stated above)
Observation:
Background information
Laboratory test
Echocardiography
Sarcopenia test (grip strength, short physical performance battery, appendicular skeletal muscle mass by bio impedance analysis)
Frail questionnaire (Fried criteria and Makizako criteria)
ADL questionnaire (IPAQ)
Change of life style in COVID-19 era (using questionnaire)
Management information
Registered date
| 2021 | Year | 04 | Month | 18 | Day |
Last modified on
| 2021 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050207
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
