UMIN-CTR Clinical Trial

Basic information
Public title	Cardiac rehabilitation for hypertrophic cardiomyopathy
Acronym	Exercise for hypertrophic cardiomyopathy
Scientific Title	Cardiac rehabilitation for hypertrophic cardiomyopathy
Scientific Title:Acronym	Exercise for hypertrophic cardiomyopathy
Region	Japan

Condition
Condition	Hypertrophic cardiomyopathy
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety and effect of exercise for patients with hypertrophic cardiomyopathy.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Heart Failure Arrhythmia total death (cardiac death) cerebral infarction
Key secondary outcomes

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	10 years-old <=
Age-upper limit	110 years-old >
Gender	Male and Female
Key inclusion criteria	patients with Hypertrophic cardiomyopathy
Key exclusion criteria	Patients who don't agree with this study. Patients who can't exercise for leg disease.
Target sample size	500

Research contact person
Name of lead principal investigator	1st name Atsuko Middle name Last name Nakayama
Organization	The University of Tokyo
Division name	Department of cardilology
Zip code	183-8655
Address	7-3-1 Hongo
TEL	+81338155411
Email	st7089-fki@umin.ac.jp

Public contact
Name of contact person	1st name Atsuko Middle name Last name Nakayama
Organization	The University of Tokyo
Division name	Department of cardilology
Zip code	183-8655
Address	7-3-1 Hongo
TEL	+81338155411
Homepage URL
Email	st7089-fki@umin.ac.jp

Sponsor
Institute	The University of Tokyo
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	JAPAN

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	The university of Tokyo Hospital
Address	Hongo 7-3-1
Tel	03-3815-5411
Email	st7089-fki@umin.ac.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

Other administrative information
Date of disclosure of the study information	2018 Year 11 Month 06 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	2004 Year 01 Month 01 Day
Date of IRB	2019 Year 07 Month 24 Day
Anticipated trial start date	2004 Year 01 Month 01 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Observational Study

Management information
Registered date	2018 Year 11 Month 06 Day
Last modified on	2019 Year 09 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039662