UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010008 |
|---|---|
| Receipt number | R000011723 |
| Scientific Title | Clinical research on application of transluminal renal arterial catheter radiofrequency ablation for blood pressure reduction in patients with drug-resistant essential hypertension |
| Date of disclosure of the study information | 2013/02/11 |
| Last modified on | 2020/02/17 09:41:55 |
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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
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
yujicardiology@gmail.com
Sponsor or person
Institute
Department of Advanced Cardiovascular Therapeutics, Osaka University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011723
