UMIN-CTR Clinical Trial

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