UMIN-CTR Clinical Trial

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
Email	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
Email	msaitoh@shi.heart.or.jp

Sponsor
Institute	Sakakibara Heart Institute
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041945