UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024293 |
|---|---|
| Receipt number | R000027852 |
| Scientific Title | Association between sleep disordered breathing and overnight changes in arterial stiffness in patients with heart failure. |
| Date of disclosure of the study information | 2016/10/10 |
| Last modified on | 2022/10/21 02:24:52 |
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Basic information
Public title
Association between sleep disordered breathing and overnight changes in arterial stiffness in patients with heart failure.
Acronym
Association between sleep disordered breathing and overnight changes in arterial stiffness in patients with heart failure.
Scientific Title
Association between sleep disordered breathing and overnight changes in arterial stiffness in patients with heart failure.
Scientific Title:Acronym
Association between sleep disordered breathing and overnight changes in arterial stiffness in patients with heart failure.
Region
| Japan |
Condition
Condition
Heart Failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the association between sleep disordered breathing and overnight changes in cardiac function, hemodynamics and arterial stiffness in patients with heart failure.
Basic objectives2
Others
Basic objectives -Others
Exploratory
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Apnea Hypopnea Index (AHI)
Cardio ankle vascular index (CAVI)
Parameters of echocardiography
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with heart failure, undergoing overnight polysomnography
Key exclusion criteria
Patients under dialysis
Patients with arteriosclerosis obliterans
Patients with limb deficiencies
Patients who are considered as inappropriate based on the principle investigators judgement
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takatoshi |
| Middle name | |
| Last name | Kasai |
Organization
Juntendo University
Division name
Cardiovascular Respiratory Sleep Medicine, Juntendo University Graduate School of Medicine
Zip code
113-8421
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo, Japan.
TEL
+81-33813-3111
kasai-t@mx6.nisiq.net
Public contact
Name of contact person
| 1st name | Takatoshi |
| Middle name | |
| Last name | Kasai |
Organization
Juntendo University
Division name
Cardiovascular Respiratory Sleep Medicine, Juntendo University Graduate School of Medicine
Zip code
113-8421
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo, Japan.
TEL
+81-33813-3111
Homepage URL
kasai-t@mx6.nisiq.net
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
we have no funding source
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
The Institutional Review Board of the Juntendo University Hospital
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo, Japan.
Tel
+81358021584
kenkyu5858@juntendo.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
| 2016 | Year | 10 | Month | 10 | 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
76
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
| 2016 | Year | 09 | Month | 23 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 23 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 10 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Before follow up
Management information
Registered date
| 2016 | Year | 10 | Month | 04 | Day |
Last modified on
| 2022 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027852
