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

Email

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


Email

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

Email

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