UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051537 |
|---|---|
| Receipt number | R000058794 |
| Scientific Title | The effect of an angiotensin receptor-neprilysin inhibitor to blood pressure and sympathoadrenal responses during mental arithmetic stress in patients with essential hypertension |
| Date of disclosure of the study information | 2023/07/06 |
| Last modified on | 2023/07/06 13:04:11 |
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Basic information
Public title
The effect of an angiotensin receptor-neprilysin inhibitor to blood pressure and sympathoadrenal responses during mental arithmetic stress in patients with essential hypertension
Acronym
The effect of an angiotensin receptor-neprilysin inhibitor to mental arithmetic stress in patients with essential hypertension
Scientific Title
The effect of an angiotensin receptor-neprilysin inhibitor to blood pressure and sympathoadrenal responses during mental arithmetic stress in patients with essential hypertension
Scientific Title:Acronym
The effect of an angiotensin receptor-neprilysin inhibitor to mental arithmetic stress in patients with essential hypertension
Region
| Japan |
Condition
Condition
essential hypertension
Classification by specialty
| Cardiology | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of an angiotensin receptor-neprilysin inhibitor, sacubitril-valsartan to blood pressure and sympathoadrenal responses during mental arithmetic stress in patients with essential hypertension
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in blood pressure and indices of sympathoadrenal system (plasma catecholamines, power spectrum analysis obtained from heart rate variability measured by Holter ECG) during mental arithmetic stress before and after treatment (sacubitril-valsartan or valsartan administration)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administration of sacubitril valsartan for one year
Interventions/Control_2
Administration of valsartan for one year
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patient with untreated essential hypertensiont
2) Patient who is between 20 and 70 years old
3) Patient who can freely give consent under a good understanding of the explanation
Key exclusion criteria
1) Patient under 20 years old or over 70 years old
2) Patient receiving angiotensin converting enzyme or within 36 hours of its discontinuation
3) Diabetic patient receiving aliskiren fumarate
4) Patient with severe hepatic impairment (Child-Pugh class C)
5) Pregnant woman or woman who may be pregnant
6) Patient judged by the research physician to be unsuitable for inclusion
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Tsutomu |
| Middle name | |
| Last name | Koike |
Organization
University of Toyama
Division name
The Second Department of Internal Medicine
Zip code
930-0194
Address
2630 Sugitani, Toyama, Toyama, Japan
TEL
076-434-7297
tkoike@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Tsutomu |
| Middle name | |
| Last name | Koike |
Organization
University of Toyama
Division name
The Second Department of Internal Medicine
Zip code
930-0194
Address
2630 Sugitani, Toyama, Toyama, Japan
TEL
076-434-7297
Homepage URL
tkoike@med.u-toyama.ac.jp
Sponsor or person
Institute
University of Toyama
Institute
Department
Personal name
Funding Source
Organization
University of Toyama
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
Ethics Committee, University of Toyama
Address
2630 Sugitani, Toyama, Toyama, Japan
Tel
076-434-7681
rinri@adm.u-toyama.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
| 2023 | Year | 07 | Month | 06 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 05 | Month | 24 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 24 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2027 | 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
| 2023 | Year | 07 | Month | 06 | Day |
Last modified on
| 2023 | Year | 07 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058794
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
