UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015544 |
|---|---|
| Receipt number | R000018044 |
| Scientific Title | Hitoyoshi Cardiovascular Rehabilitation Study |
| Date of disclosure of the study information | 2014/10/28 |
| Last modified on | 2019/11/07 17:07:34 |
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Basic information
Public title
Hitoyoshi Cardiovascular Rehabilitation Study
Acronym
HARVEST
Scientific Title
Hitoyoshi Cardiovascular Rehabilitation Study
Scientific Title:Acronym
HARVEST
Region
| Japan |
Condition
Condition
Cardiovascular Disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluating the effect of exercise therapy on patients with cardiovascular disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival rate
Key secondary outcomes
Blood Pressure, Body weight, Cognitive function tests, Blood sampling (parameter of glycolipid and inflammation, Metabolic Marker etc), Urine sampling, Assessment of cardiac function by echocardiography, Assessment of exercise and cardiopulmonary function by cardiopulmonary exercise testing
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with cardiovascular disease
2) Subjects who gave written informed consent
Key exclusion criteria
1) Subjects who are impossible to exercise
2) Pregnant
3) Subjects whose doctor in charge do not agree to join the trial
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Kensuke |
| Middle name | |
| Last name | Toyama |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Pharmacology
Zip code
790-0295
Address
454 Shitsukawa,Touon city, Ehime, 790-0295, Japan
TEL
089-960-5259
k-toyama@m.ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuri |
| Middle name | |
| Last name | Iwasaki |
Organization
Hitoyoshi Medical Center
Division name
Clinical Research Center
Zip code
8688555
Address
35 Oikami, Hitoyoshi city, Kumamoto, Japan
TEL
0966-22-2191
Homepage URL
iwasaki-yuri@hitoyoshi.jcho.go.jp
Sponsor or person
Institute
Division of Cardiology, Hitoyoshi Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
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
Japan Community Healthcare Organization Hitoyoshi Medical Center Institutional review board
Address
35oikami-machi,hitoyoshi,kumamoto868-8555,Japan
Tel
0966-22-2191
iwasaki-yuri@hitoyoshi.jcho.go.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
| 2014 | Year | 10 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
43
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
Completed
Date of protocol fixation
| 2011 | Year | 03 | Month | 10 | Day |
Date of IRB
| 2011 | Year | 03 | Month | 10 | Day |
Anticipated trial start date
| 2011 | Year | 03 | Month | 10 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 07 | Day |
Date of closure to data entry
| 2019 | Year | 11 | Month | 07 | Day |
Date trial data considered complete
| 2019 | Year | 11 | Month | 07 | Day |
Date analysis concluded
| 2019 | Year | 11 | Month | 07 | Day |
Other
Other related information
Overall survival rate, Cognitive function tests, Parameter of glycolipid and inflammation, Metabolic Marker, Assessment of cardiac function by echocardiography, Assessment of exercise and cardiopulmonary function by cardiopulmonary exercise testing
Management information
Registered date
| 2014 | Year | 10 | Month | 28 | Day |
Last modified on
| 2019 | Year | 11 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018044
