UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039905 |
|---|---|
| Receipt number | R000045330 |
| Scientific Title | Analysis of long-term prognosis of renal denavation therapy treated at Fukuoka University Chikushi Hospital |
| Date of disclosure of the study information | 2020/04/01 |
| Last modified on | 2025/05/12 11:20:18 |
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Basic information
Public title
Analysis of long-term prognosis of renal denavation therapy treated at Fukuoka University Chikushi Hospital
Acronym
Long-term prognosis analysis of RDN treatment
Scientific Title
Analysis of long-term prognosis of renal denavation therapy treated at Fukuoka University Chikushi Hospital
Scientific Title:Acronym
Long-term prognosis analysis of RDN treatment
Region
| Japan |
Condition
Condition
Treatment-resistant hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In RDN clinical trials, we observe the effect persistence and safety for 1 to 3 years after the RDN procedure within the trial rules. However, there is not yet sufficient evidence as to whether the efficacy and safety of the RDN will continue for as long as four or five years. In this study, we will investigate whether the efficacy and safety of RDN after the follow-up of clinical trials will continue until 5 years after the procedure. Evaluating the long-term prognosis of RDN may provide valuable evidence in determining which hypertensive patients will have benefit from RDN in the future.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Difference in ABPM before and 5 years after the procedure
Key secondary outcomes
Difference in SBP / DBP of OBP before and 1, 2, 3, 4, and 5 years after the procedure
Difference in SBP / DBP of home blood pressure before and 1, 2, 3, 4, and 5 years after the procedure
Difference in ABPM SBP / DBP before and 1, 2, 3, 4 and 5 years after the procedure (only when performed in regular clinical practice)
Changes in antihypertensive drugs before and 1, 2, 3, 4, and 5 years after the procedure
Difference in taking rate of antihypertensive drug before and 1, 2, 3, 4, and 5 years after the procedure
Presence or absence of events (cerebral infarction, myocardial infarction, etc.) related to (possibly) hypertension up to 1, 2, 3, 4 or 5 years after the procedure
Search for regulatory factors related to BP lowering effect
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who performed renal denaturation procedure in clincal trials(A and B study)
Patients who have given written consent
Key exclusion criteria
Patients who do not meet inclusion criteria
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Osamu |
| Middle name | |
| Last name | Imakyure |
Organization
Fukuoka University Chikushi Hospital
Division name
Pharmacy Department
Zip code
818-8502
Address
1-1-1,Zokumyoin,chikushino-shi,Fukuoka
TEL
092-921-1011
imakyure@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | Hideaki |
| Middle name | |
| Last name | Shimada |
Organization
Fukuoka University Chikushi Hospital
Division name
Clinical Research Support Center
Zip code
818-8502
Address
1-1-1,Zokumyoin,chikushino-shi,Fukuoka
TEL
092-921-1011
Homepage URL
hideakishimada@fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University
Institute
Department
Personal name
Funding Source
Organization
Fukuoka University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Okamura Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukuoka University-Medical EthicsReviewBoard
Address
7-45-1 Nanakuma, Jonan-kuFukuoka 814-0180, JAPAN
Tel
092-801-1011
fumed-ethics@fukuoka-u.ac.jp
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
| 2020 | Year | 04 | Month | 01 | 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
8
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 03 | Month | 17 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 05 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 17 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Difference in ABPM SBP / DBP before and 1, 2, 3, 4 and 5 years after the procedure
Management information
Registered date
| 2020 | Year | 03 | Month | 23 | Day |
Last modified on
| 2025 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045330
