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 |
Analysis of long-term prognosis of renal denavation therapy treated at Fukuoka University Chikushi Hospital
Long-term prognosis analysis of RDN treatment
Analysis of long-term prognosis of renal denavation therapy treated at Fukuoka University Chikushi Hospital
Long-term prognosis analysis of RDN treatment
Japan |
Treatment-resistant hypertension
Cardiology |
Others
NO
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.
Safety,Efficacy
Difference in ABPM before and 5 years after the procedure
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
Observational
20 | years-old | <= |
80 | years-old | >= |
Male and Female
Patients who performed renal denaturation procedure in clincal trials(A and B study)
Patients who have given written consent
Patients who do not meet inclusion criteria
10
1st name | Osamu |
Middle name | |
Last name | Imakyure |
Fukuoka University Chikushi Hospital
Pharmacy Department
818-8502
1-1-1,Zokumyoin,chikushino-shi,Fukuoka
092-921-1011
imakyure@fukuoka-u.ac.jp
1st name | Hideaki |
Middle name | |
Last name | Shimada |
Fukuoka University Chikushi Hospital
Clinical Research Support Center
818-8502
1-1-1,Zokumyoin,chikushino-shi,Fukuoka
092-921-1011
hideakishimada@fukuoka-u.ac.jp
Fukuoka University
Fukuoka University
Self funding
Okamura Clinic
Fukuoka University-Medical EthicsReviewBoard
7-45-1 Nanakuma, Jonan-kuFukuoka 814-0180, JAPAN
092-801-1011
fumed-ethics@fukuoka-u.ac.jp
NO
2020 | Year | 04 | Month | 01 | Day |
Unpublished
8
No longer recruiting
2020 | Year | 03 | Month | 17 | Day |
2020 | Year | 03 | Month | 05 | Day |
2020 | Year | 04 | Month | 17 | Day |
2025 | Year | 06 | Month | 30 | Day |
Difference in ABPM SBP / DBP before and 1, 2, 3, 4 and 5 years after the procedure
2020 | Year | 03 | Month | 23 | Day |
2025 | Year | 05 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045330