UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012020 |
|---|---|
| Receipt number | R000014034 |
| Scientific Title | Study of Renal Sympathetic Denervation with Radiofrequency Ablation Catheter for Resitant Essential Hypertension |
| Date of disclosure of the study information | 2013/10/27 |
| Last modified on | 2019/06/12 09:30:44 |
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Basic information
Public title
Study of Renal Sympathetic Denervation with Radiofrequency Ablation Catheter for Resitant Essential Hypertension
Acronym
Study of Renal Denervation for Hypertension
Scientific Title
Study of Renal Sympathetic Denervation with Radiofrequency Ablation Catheter for Resitant Essential Hypertension
Scientific Title:Acronym
Study of Renal Denervation for Hypertension
Region
| Japan |
Condition
Condition
Drug-Resistant Essential Hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Assessing safety and effectivess of renal sympathetic denervation in Japanese patients by the method of muscle sympathetic nerve activity
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
1)Safety during perioperative period and chronic phase after the operation(evaluated with eGFR and imaging study)
2)Onset or progression of cardiovascular disease
Key secondary outcomes
1)Safety of the technique in the operation
2)Systolic blood pressure one year after the operation
3)Sympathetic nerve activity after the operartion(evaluated with muscle sympathetic nerve activity and blood hormone such as catecholamine)
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
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Renal sympathetic denervation with radiofrequency ablation catheter
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients whose systolic pressure is beyond 160mmHg in spite of taking more than 3 kinds of antihypertensive drug(patients whose systolic pressure is beyond 150mmHg, if he is a diabetic)
Key exclusion criteria
1)Anatomical anomaly of renal artery inappropriate for the operation
2)Estimated glomerular filtration rate is less than 45mL/min
3)History of myocardial infarction, angina pectoris, or cerebrovascular accident within 6 month
4)Type1 diabetes mellitus
5)Secondary Hypertension
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shuichi Kaneko |
Organization
Kanazawa University Graduate School of Medical Science, Division of Environmental Science
Division name
Disease Control and Homeostasis
Zip code
Address
Takaramachi13-1, Kanazawa City, Ishikawa Prefecture
TEL
076-265-2000
skaneko@m-kanazawa.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hisayoshi Murai |
Organization
Kanazawa University Graduate School of Medical Science, Division of Environmental Science
Division name
Disease Control and Homeostasis
Zip code
Address
Takaramachi13-1, Kanazawa City, Ishikawa Prefecture
TEL
076-265-2000
Homepage URL
sakurasoma1209@yahoo.co.jp
Sponsor or person
Institute
Kanazawa University Graduate School of Medical Science, Division of Environmental Sience
Disease Control and Homeostasis
Institute
Department
Personal name
Funding Source
Organization
Medical Science, Division of Environmental Sience
Disease Control and Homeostasis
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Department of Cardiovascular Medicine Osaka University graduate School of Medicine
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
金沢大学附属病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 10 | Month | 27 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 04 | Month | 26 | Day |
Date of IRB
| 2013 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2013 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
move to other data base
Management information
Registered date
| 2013 | Year | 10 | Month | 11 | Day |
Last modified on
| 2019 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014034
| 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 |
