UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036818 |
|---|---|
| Receipt number | R000041945 |
| Scientific Title | Cardiovascular physiotherapy for acute heart failure patients in the Tokyo metropolitan area study |
| Date of disclosure of the study information | 2019/05/22 |
| Last modified on | 2022/02/24 15:16:21 |
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Basic information
Public title
Cardiovascular physiotherapy for acute heart failure patients in the Tokyo metropolitan area study
Acronym
CRAFTSMAN study
Scientific Title
Cardiovascular physiotherapy for acute heart failure patients in the Tokyo metropolitan area study
Scientific Title:Acronym
CRAFTSMAN study
Region
| Japan |
Condition
Condition
heart failure
Classification by specialty
| Cardiology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examined the acute phase of physiotherapy, trajectory of functional status, activities of daily living, and evaluate the impact of these variate in outcome in patients diagnosed with acute heart failure.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Mortality
Key secondary outcomes
readmission due to heart failure
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Acute heart failure patients received acute phase of physiotherapy during hospitalization
Key exclusion criteria
Patient death in hospital
Target sample size
2500
Research contact person
Name of lead principal investigator
| 1st name | Saitoh |
| Middle name | |
| Last name | Masakazu |
Organization
Sakakibara Heart Institute
Division name
Department of Rehabilitation
Zip code
1830003
Address
3-16-1, Asahi-cho, Fuchu 1830003, Tokyo
TEL
042-314-3111
msaitoh@shi.heart.or.jp
Public contact
Name of contact person
| 1st name | Masakazu |
| Middle name | |
| Last name | Saitoh |
Organization
Sakakibara Heart Institute
Division name
Department of Rehabilitation
Zip code
1830003
Address
3-16-1, Asahi-cho, Fuchu 1830003, Tokyo
TEL
042-314-3111
Homepage URL
msaitoh@shi.heart.or.jp
Sponsor or person
Institute
Sakakibara Heart Institute
Institute
Department
Personal name
Funding Source
Organization
Sakakibara Heat Institute
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sakakibara Heart Institute
Address
3-16-1, Asahi-cho, Fuchu 1830003, Tokyo
Tel
042-314-3111
kenkyu@shi.heart.or.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
東京都
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 05 | Month | 22 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/33838022/
Publication of results
Partially published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/33838022/
Number of participants that the trial has enrolled
1941
Results
The primary outcome of this study was all-cause death and HF readmission. A total of 565 (29%) deaths and 789 (41%) HF readmission occurred over a median follow-up period of 1.7 years. A total of 476 patients (25%) had HAD during hospital stay after acute HF.
Results date posted
| 2022 | Year | 02 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 04 | Month | 01 | Day |
Baseline Characteristics
acute heart failure patients aged 65 years or older
Participant flow
1941 elderly patients aged 65 years or older from the cardiovascular physiotherapy for acute HF patients in the Tokyo metropolitan area registry and excluded those who died in hospital
Adverse events
no
Outcome measures
All-cause mortality
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 05 | Month | 28 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 28 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 12 | Month | 31 | Day |
Other
Other related information
we evaluated the outcome in patients enrolled ouor cohort study between April 2014 and March 2018
Management information
Registered date
| 2019 | Year | 05 | Month | 22 | Day |
Last modified on
| 2022 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041945
