UMIN-CTR Clinical Trial

Basic information
Public title	Clinical research on application of transluminal renal arterial catheter radiofrequency ablation for blood pressure reduction in patients with drug-resistant essential hypertension
Acronym	Renal arterial catheter ablation for drug-resistant essential hypertension
Scientific Title	Clinical research on application of transluminal renal arterial catheter radiofrequency ablation for blood pressure reduction in patients with drug-resistant essential hypertension
Scientific Title:Acronym	Renal arterial catheter ablation for drug-resistant essential hypertension
Region	Japan

Condition
Condition	Essential hypertension
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety and efficacy of intra-renal arterial catheter radiofrequency ablation on reducing blood pressure in patients with essential hypertension that cannot achieve normalized blood pressure with more than three kinds of anti-hypertensive medication.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	1) No severe adverse effect after completion of protocol. 2) Lower blood pressure measures after 1, 3, 6, 12 months of operation than control with unchanged medication, or normalized pressure with reduced medication.
Key secondary outcomes

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	Device,equipment
Interventions/Control_1	All participants undergo percutaneous transluminal catheter radiofrequency ablation in renal artery with 5Fr ablation catheter approved for treating cardiac arrhythmia. Initial 3 cases undergo 4W x 60sec ablation for 4 points. If they do not achieve mean systolic blood pressure reduction of over 10mmHg at 1 months later, another 3 cases undergo 6W x 60sec ablation for 4 points.
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	1) Maintaining systolic blood pressure not less than 160mmHg (or 150mmHg with diabetes mellitus) under 3 or more kinds of anti-hypertensive medication. 2) Undergoing introduction about this study and give written informed consent.
Key exclusion criteria	1) Renal anomaly or incompetency: Narrowing, previous renal angioplasty or stenting, or bifurcation. 2) Estimated glomerular filtration ratio less than 45mL/min. 3) Myocardial infarction, angina pectoris, or cerebrovascular disorder within recent 6 months. 4) Type 1 diabetes. 5) Secondary hypertension. 6) Prominent bleeding risk or coagulating disorder. 7) Diagnosed as any non-cardiovascular disease with less than 12 months more to live. 8) Current participants for any other clinical trial, excluding under extended observation period for evaluating approved drugs or materials. 9) Pregnancy. 10) Disqualified by any cardiologist for participating in this study.
Target sample size	6

Research contact person
Name of lead principal investigator	1st name Middle name Last name Issei Komuro
Organization	Osaka University Graduate School of Medicine
Division name	Department of Cardiovascular Medicine
Zip code
Address	2-2, Yamadaoka, Suita, Osaka, Japan
TEL
Email

Public contact
Name of contact person	1st name Middle name Last name Yuji Okuyama
Organization	Osaka University Graduate School of Medicine
Division name	Department of Advanced Cardiovascular Therapeutics
Zip code
Address	2-2, Yamadaoka, Suita, Osaka, Japan
TEL
Homepage URL
Email	yujicardiology@gmail.com

Sponsor
Institute	Department of Advanced Cardiovascular Therapeutics, Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization	None
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
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	大阪大学医学部附属病院（大阪府）

Other administrative information
Date of disclosure of the study information	2013 Year 02 Month 11 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	Completed
Date of protocol fixation	2011 Year 08 Month 07 Day
Date of IRB	2011 Year 09 Month 30 Day
Anticipated trial start date	2011 Year 10 Month 01 Day
Last follow-up date	2015 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	2013 Year 02 Month 11 Day
Last modified on	2020 Year 02 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011723