UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020835 |
|---|---|
| Receipt number | R000024053 |
| Scientific Title | A study of renal denervation in patients with refractory hypertension |
| Date of disclosure of the study information | 2016/02/15 |
| Last modified on | 2016/02/01 20:15:56 |
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Basic information
Public title
A study of renal denervation in patients with
refractory hypertension
Acronym
renal denervation for refractory hypertension
Scientific Title
A study of renal denervation in patients with
refractory hypertension
Scientific Title:Acronym
renal denervation for refractory hypertension
Region
| Japan |
Condition
Condition
refractory essential hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate efficacy and safety of renal denervation in patients with refractory essential hypertension and to assess procedural endpoint by renal pacing
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Blood pressure elevation during renal pacing or renal denervation,
Changes in blood pressure between before
and after procedure at 1,3,6,and 12 months,
Changes in ABPM between before and after
procedure at 1,3,6,and 12 months,
Relationship between post procedural blood pressure elevation during renal pacing and
blood pressure lowering at follow-up period
Key secondary outcomes
vital changes (blood pressure, heart rate) and pain during renal pacing,
renal stenosis 3 months after procedure
assessed by CT or MRI,
Changes in laboratory data between before
and after procedure at 1w, 1,3,6,and 12
months
Adverse events
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
renal denervation
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. aged between 20 and 85 years old
2. a systolic blood pressure of >=160mmHg
(>=150mmHg for Diabetes), despite
compliance with three or more
antihypertensive drugs
3. obtained written informed consent
Key exclusion criteria
1. renal artery stenosis of more than 25%,
renal stent implnataion, dual renal arteries
2. eGFR <30mL/min/1,73m2
3. average systolic BP <135mmmHg by ABPM
4. myocardial infarction or coronary
intervention within 6 months
5. diabetes requiring insulin (type 1 diabetes)
6. secondary hypertension
7. bleeding tendency or impairment of
coagulation system
8. terminal illness with life expectancy less
than 12 months
9. participating in other clinical trial
10. pregnancy
11. ineligible for the trial
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasushi Sakata |
Organization
Osaka University Graduate School of
Medicine
Division name
Cardiovascular medicine
Zip code
Address
2-2 Yamadaoka Suita Osaka, Japan
TEL
+81-6-6879-3631
yasushisk@cardiology.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuji Okuyama |
Organization
Osaka University Graduate School of Medicine
Division name
Advanced Cardiovascular Therapeutics
Zip code
Address
2-2 Yamadaoka Suita Osaka, Japan
TEL
+81-6-6879-3638
Homepage URL
yujicardiology@gmail.com
Sponsor or person
Institute
Osaka University Graduate School of
Medicine, Cardiovascular medicine
Institute
Department
Personal name
Funding Source
Organization
Osaka University Graduate School of
Medicine, Cardiovascular medicine
Organization
Division
Category of Funding Organization
Other
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2016 | Year | 01 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 01 | Day |
Last modified on
| 2016 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024053
