UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017142 |
|---|---|
| Receipt number | R000019880 |
| Scientific Title | Evaluation of hemodynamic changes during sleep study and while on positive airway pressure in patients with heart failure |
| Date of disclosure of the study information | 2015/04/15 |
| Last modified on | 2023/10/24 09:04:27 |
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Basic information
Public title
Evaluation of hemodynamic changes during sleep study and while on positive airway pressure in patients with heart failure
Acronym
Hemodynamics during sleep and while on positive airway pressure in heart failure
Scientific Title
Evaluation of hemodynamic changes during sleep study and while on positive airway pressure in patients with heart failure
Scientific Title:Acronym
Hemodynamics during sleep and while on positive airway pressure in heart failure
Region
| Japan |
Condition
Condition
Heart Failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate hemodynamic changes during sleep and while on positive airway pressure in patients with heart failure
Basic objectives2
Others
Basic objectives -Others
Clinical utility
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in hemodynamic parameters
Key secondary outcomes
Base
Study type
Study design
Basic design
Single arm
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
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
non-invasive positive airway pressure 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Heart failure patients who are undergoing sleep study
or
2) Heart failure patients who are undergoing positive airway pressure therapy for sleep disordered breathing or for heart failure
and
3) patients who gave written informed consent
Key exclusion criteria
<20 years old
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takatoshi Kasai |
Organization
Juntendo Hospital, Juntendo University School of Medicine
Division name
Cardiology
Zip code
Address
2-1-1 Hongo, Bunkyoku, Tokyo, Japan
TEL
03-3813-3111
tkasai@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takatoshi Kasai |
Organization
Juntendo Hospital, Juntendo University School of Medicine
Division name
Cardiology
Zip code
Address
2-1-1 Hongo, Bunkyoku, Tokyo, Japan
TEL
03-3813-3111
Homepage URL
tkasai@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Juntendo University Graduate School of Medicine
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
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 04 | Month | 15 | 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
| 2015 | Year | 04 | Month | 15 | Day |
Date of IRB
| 2015 | Year | 04 | Month | 15 | Day |
Anticipated trial start date
| 2015 | Year | 04 | Month | 20 | Day |
Last follow-up date
| 2025 | Year | 03 | 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
| 2015 | Year | 04 | Month | 15 | Day |
Last modified on
| 2023 | Year | 10 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019880
