UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031942 |
|---|---|
| Receipt number | R000036458 |
| Scientific Title | A prospective clinical trial on effects of Suvorexant on Respiration and Hemodynamics during Sleep in Heart Failure patients. |
| Date of disclosure of the study information | 2018/03/28 |
| Last modified on | 2024/04/05 11:10:47 |
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Basic information
Public title
A prospective clinical trial on effects of Suvorexant on Respiration and Hemodynamics during Sleep in Heart Failure patients.
Acronym
A prospective clinical trial on effects of Suvorexant on Respiration and Hemodynamics during Sleep in Heart Failure patients.
Scientific Title
A prospective clinical trial on effects of Suvorexant on Respiration and Hemodynamics during Sleep in Heart Failure patients.
Scientific Title:Acronym
A prospective clinical trial on effects of Suvorexant on Respiration and Hemodynamics during Sleep in Heart Failure patients.
Region
| Japan |
Condition
Condition
heart failure, insomnia
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of suvorexant on breathing and hemodynamics during sleep in heart failure patients with insomnia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Apnea Hypopnea Index
Key secondary outcomes
Cardiac Output, Stroke volume, Blood pressure, Total peripheral resistance, Heart rate
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administer Suvorexant (orexin receptor antagonist) for four days. Patients less than 65 years old will be administered a single 20 mg oral dose of suvorexant and patients over 65 years old will be administered a single 15 mg oral dose of suvorexant.
Interventions/Control_2
Not sleep medications as control.
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)Patients admitted due to care of heart failure and diagnosed insomnia
and
2)Patients who gave written informed consent
Key exclusion criteria
1)Patients being dialysis
2)Patients can not take medicine orally
3)Patients using incompatible medicine which cause a major interaction with suvorexant.
4)Past organic cerebral disease
5)Severe liver dysfuncton
6)Patients applied inapropriate by responsible person
7)Patients have shock vital
8)Patietns using alpha blocker or nitrate medicine
9)Patients using oxygen therapy
10)Patients using CPAP therapy
11)Paitnets with pacemaker rhythm
12)Narcolepsy, Parasomnia or Sleep-related hypoventilation disorder
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takatoshi |
| Middle name | |
| Last name | Kasai |
Organization
Juntendo Hospital, Juntendo University School of Medicine
Division name
Cardiovascular Medicine
Zip code
113-8431
Address
2-1-1 Hongo, Bunkyoku, Tokyo, Japan
TEL
03-3813-3111
tkasai@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Shitara |
Organization
Juntendo Hospital, Juntendo University School of Medicine
Division name
Cardiovascular Medicine
Zip code
113-8431
Address
2-1-1 Hongo, Bunkyoku, Tokyo, Japan
TEL
03-3813-3111
Homepage URL
jshitara@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
we have no funding source
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
Juntendo University ethics committee
Address
3-1-3 Hongo Bunkyo-ku Tokyo
Tel
03-5802-1584
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
| 2018 | Year | 03 | Month | 28 | 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
| 2017 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 26 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 26 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 12 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 28 | Day |
Last modified on
| 2024 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036458
