UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004258 |
|---|---|
| Receipt number | R000005105 |
| Scientific Title | Development of the care program for the patients with heart failure using leg thermal therapy to improve their QOL and prognosis |
| Date of disclosure of the study information | 2010/11/01 |
| Last modified on | 2015/05/12 14:51:57 |
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Basic information
Public title
Development of the care program for the patients with heart failure using leg thermal therapy to improve their QOL and prognosis
Acronym
Leg thermal therapy for the patients with heart failure
Scientific Title
Development of the care program for the patients with heart failure using leg thermal therapy to improve their QOL and prognosis
Scientific Title:Acronym
Leg thermal therapy for the patients with heart failure
Region
| Japan |
Condition
Condition
Stable patients with heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate effects and safety of the Leg thermal therapy on the patients with heart failure
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Cardiovascular events (cardiac death, hospital admission by heart failure, a new episode of arrhythmia, thromboembolism, abnormal blood pressure)
Key secondary outcomes
1) electrocardiographic findings
2) Flow mediated endotherial function
3) Chest X ray examination
4) Biomarkers in peripheral blood and urine
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Leg thermal therapy
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) stable patients with heart failure
aged from 20 to 85yo.
2) patients with NYHA II-III
3) patients being able to stay at the University Hospital or to visit the outpatient clinic.
4)patients with written informed consent for this study
Key exclusion criteria
1) patients with unstable hemodynamic state or acute state
2) patients under 20yo or over 85yo
3) patients with NYHA IV
4) patients with mental diseases, demented state, and severe non-cardiac diseases
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akiko Chishaki |
Organization
Kyushu University Graduate School of Medical Sciences
Division name
Health Sciences
Zip code
Address
3-1-1 Maidashi, Higashiku, Fukuoka
TEL
092-642-6713
chishaki@hs.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akiko Chishaki |
Organization
Kyushu University Graduate School of Medical Sciences
Division name
Health Sciences
Zip code
Address
3-1-1 Maidashi, Higashiku, Fukuoka
TEL
092-642-6713
Homepage URL
chishaki@hs.med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University Graduate School of Medical Sciences Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Hokkaido University, Asahikawa Medical University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
九州大学病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 11 | 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
Completed
Date of protocol fixation
| 2010 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 09 | Month | 24 | Day |
Last modified on
| 2015 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005105
| Research Plan | |
|---|---|
| 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 |
