UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056074 |
|---|---|
| Receipt number | R000064029 |
| Scientific Title | CLOVER - Cerebral Low Oxygen and Vascular Evaluation in Relapse (indicating orthostatic events or syncope) |
| Date of disclosure of the study information | 2024/11/10 |
| Last modified on | 2024/11/06 14:49:55 |
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Basic information
Public title
Investigation of cerebral blood flow changes in patients with orthostatic hypotension
Acronym
CLOVER - Cerebral Low Oxygen and Vascular Evaluation in Relapse (indicating orthostatic events or syncope)
Scientific Title
CLOVER - Cerebral Low Oxygen and Vascular Evaluation in Relapse (indicating orthostatic events or syncope)
Scientific Title:Acronym
Investigation of cerebral blood flow changes in patients with orthostatic hypotension
Region
| Japan |
Condition
Condition
Patients with neurological disorders that may cause autonomic neuropathy
Examples: Parkinson's disease, dementia with Lewy bodies, pure autonomic failure, multiple system atrophy, corticobasal ganglia degeneration, progressive supranuclear palsy, spinocerebellar degeneration, familial amyloid polyneuropathy, autoimmune autonomic ganglionopathy, diabetic neuropathy, Sjogren's syndrome, paraneoplastic neurologic syndromes, autoimmune CNS inflammatory diseases, vasculitis syndromes
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Symptoms of dizziness and syncope are caused by reduced cerebral blood flow due to orthostatic hypotension. The purpose of this study is to evaluate changes in blood pressure and cerebral blood flow during the head-up tilt test and some activities of daily living. This will lead to the elucidation of the pathophysiology of orthostatic hypotension and the investigation of new countermeasures.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
concentration of oxygenated hemoglobin
Key secondary outcomes
Serum BDNF, serum GFAP, serum UCH-L1, serum NfL, MMSE, FAB
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Cerebral blood flow is measured by near-infrared spectroscopy using HOT-2000 manufactured by NeU.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with neurological diseases that may cause autonomic neuropathy
Examples: Parkinson's disease, dementia with Lewy bodies, pure autonomic failure, multiple system atrophy, corticobasal degeneration, progressive supranuclear palsy, spinocerebellar degeneration, familial amyloid polyneuropathy, autoimmune autonomic ganglionopathy, diabetic neuropathy, Sjogren's syndrome, paraneoplastic neurologic syndromes, autoimmune central nervous system inflammatory disease, vasculitis syndrome
Key exclusion criteria
Pregnant or at risk of pregnancy.
Patients with stroke or with a history of stroke.
Patients with neuroendocrine tumor.
Patients who are not able to cross their legs, push, hold a standing position, and walk.
Patients who are judged by the investigator to be inappropriate to participate in this study.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tomohiko |
| Middle name | |
| Last name | Nakamura |
Organization
Hamamatsu University Hospital
Division name
department of neurology
Zip code
4313192
Address
1-20-1 Handayama, Chuo-ku, Hamamatsu city, Shizuoka, Japan
TEL
053-435-2111
takenouchi@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Akiyuki |
| Middle name | |
| Last name | Takenouchi |
Organization
Hamamatsu University School of Medicine
Division name
department of neurology
Zip code
4313192
Address
1-20-1 Handayama, Chuo-ku, Hamamatsu city, Shizuoka, Japan
TEL
053-435-2111
Homepage URL
takenouchi@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hamamatsu University School of Medicine department of neurology
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
Center of clinical research, Hamamatsu University Hospital
Address
1-20-1 Handayama, Chuo-ku, Hamamatsu city, Shizuoka, Japan
Tel
053-435-2850
crmanager@hama-med.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
| 2024 | Year | 11 | 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
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
Preinitiation
Date of protocol fixation
| 2024 | Year | 10 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 11 | Month | 10 | Day |
Last follow-up date
| 2026 | 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
| 2024 | Year | 11 | Month | 06 | Day |
Last modified on
| 2024 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064029
