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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000012020
Receipt No. 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

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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
Email 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
Email sakurasoma1209@yahoo.co.jp

Sponsor
Institute Kanazawa University Graduate School of Medical Science, Division of Environmental Sience
Disease Control and Homeostasis
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014034

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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