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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017110
Receipt No. R000019848
Scientific Title Effects of percutaneous transluminal renal angioplasty on systemic blood pressure evaluated with 24-hour monitoring
Date of disclosure of the study information 2015/04/12
Last modified on 2015/10/10

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Basic information
Public title Effects of percutaneous transluminal renal angioplasty on systemic blood pressure evaluated with 24-hour monitoring
Acronym Effects of percutaneous transluminal renal angioplasty on systemic blood pressure evaluated with 24-hour monitoring
Scientific Title Effects of percutaneous transluminal renal angioplasty on systemic blood pressure evaluated with 24-hour monitoring
Scientific Title:Acronym Effects of percutaneous transluminal renal angioplasty on systemic blood pressure evaluated with 24-hour monitoring
Region
Japan

Condition
Condition Renovascular hypertension
Classification by specialty
Medicine in general Cardiology Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the effects of percutaneous transluminal renal angioplasty (PTRA) on blood pressure (BP) response by 24-hour BP monitoring (ABPM), and identify preoperative features that predict sufficient BP improvements to PTRA.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 24-hour systemic blood pressure at 1-month after PTRA
Key secondary outcomes 24-hour systemic blood pressure at 12-month after PTRA

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who meet the following conditions.
1. Patients suffering refractory hypertension who presented systolic BP >140 mmHg documented at least 3 times on different clinic visit under two or more antihypertensive medications.
2. Patients with angiographically severe stenosis in renal artery were tested for translesional pressure gradient (TLPG) by pressure detectable wire (Pressure Wire Certus, St. Jude Medical) under hyperemic condition that was induced by intrarenal artery administration of 30 mg of papaverine.
Key exclusion criteria Patients on regular hemodialysis, or patients without written informed consent.
Target sample size 30

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Kentaro Jujo
Organization Nishiarai Heart Center Hospital
Division name Department of Cardiology
Zip code
Address 1-12-8, Nishiarai Honcho, Adachi-ku, Tokyo, Japan
TEL +81358380730
Email juken1123@hotmail.co.jpmail

Public contact
1st name of contact person
1st name
Middle name
Last name Kentaro Jujo
Organization Nishiarai Heart Center Hospitalart
Division name Department of Cardiology
Zip code
Address 1-12-8 Nishiarai-honcho, Adachi-ku, Tokyo, Japan
TEL +81358380730
Homepage URL
Email juken1123@hotmail.co.jp

Sponsor
Institute Nishiarai Heart Center Hospital
Institute
Department

Funding Source
Organization NA
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
Email

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
2015 Year 04 Month 12 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
2010 Year 12 Month 12 Day
Date of IRB
Anticipated trial start date
2011 Year 08 Month 01 Day
Last follow-up date
2015 Year 02 Month 05 Day
Date of closure to data entry
2015 Year 02 Month 05 Day
Date trial data considered complete
2015 Year 02 Month 05 Day
Date analysis concluded
2015 Year 04 Month 01 Day

Other
Other related information Prospectively enrollment
Retrospectively analysis

Management information
Registered date
2015 Year 04 Month 12 Day
Last modified on
2015 Year 10 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019848

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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