UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036264 |
|---|---|
| Receipt number | R000041306 |
| Scientific Title | Does positional therapy improve quality of life in patients with heart failure? |
| Date of disclosure of the study information | 2019/05/01 |
| Last modified on | 2025/03/24 16:25:01 |
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Basic information
Public title
Does positional therapy improve quality of life in patients with heart failure?
Acronym
Positional therapy for heart failure patients
Scientific Title
Does positional therapy improve quality of life in patients with heart failure?
Scientific Title:Acronym
Positional therapy for heart failure patients
Region
| Japan |
Condition
Condition
Heart failure
Participants who do not have any overt cardiovascular diseases
Classification by specialty
| Cardiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify cardiac load and hemodynamic status with different body position in patients with heart failure
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To clarify which body position reduce cardiac overload in patients with heart failure.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Heart failure or not
Interventions/Control_2
To change body positioning
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
| 89 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Chronic heart failure patients
Key exclusion criteria
Participants who can not tolerate breath holding.
Claustrophobia.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Masahiko |
| Middle name | |
| Last name | Kato |
Organization
Faculty of Medicine Tottori University
Division name
Division of Molecular Medicine and Therapeutics
Zip code
683-8503
Address
86 Nishichou Yonago Tottori
TEL
0859386517
mkato@tottori-u.ac.jp
Public contact
Name of contact person
| 1st name | Masahiko |
| Middle name | |
| Last name | Kato |
Organization
Faculty of Medicine Tottori University
Division name
Division of Molecular Medicine and Therapeutics
Zip code
683-8503
Address
86 Nishichou Yonago Tottori
TEL
0859386517
Homepage URL
mkato@tottori-u.ac.jp
Sponsor or person
Institute
Faculty of Medicine Tottori University
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
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tottori University Hospital
Address
36-1 Nishichou Yonago Tottori
Tel
0859386745
amirt@ml.med.tottori-u.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
| 2019 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
Not applicable
Publication of results
Unpublished
Result
URL related to results and publications
Not applicable
Number of participants that the trial has enrolled
0
Results
The study was canceled due to COVID19 pandemic.
Results date posted
| 2025 | Year | 03 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The study was canceled due to COVID19 pandemic.
Participant flow
The study was canceled due to COVID19 pandemic.
Adverse events
The study was canceled due to COVID19 pandemic.
Outcome measures
The study was canceled due to COVID19 pandemic.
Plan to share IPD
The study was canceled due to COVID19 pandemic.
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2019 | Year | 03 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 03 | Month | 20 | Day |
Last modified on
| 2025 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041306
