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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000005664
Receipt No. R000006698
Scientific Title Effect of Angiotensin II receptor blockers in hypertensive patients with persistent atrial fibrillation after electrical defibrillation
Date of disclosure of the study information 2011/06/01
Last modified on 2011/05/27

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Basic information
Public title Effect of Angiotensin II receptor blockers in hypertensive patients with persistent atrial fibrillation after electrical defibrillation
Acronym Effect of Angiotensin II receptor blockers in hypertensive patients with persistent atrial fibrillation after electrical defibrillation
Scientific Title Effect of Angiotensin II receptor blockers in hypertensive patients with persistent atrial fibrillation after electrical defibrillation
Scientific Title:Acronym Effect of Angiotensin II receptor blockers in hypertensive patients with persistent atrial fibrillation after electrical defibrillation
Region
Japan

Condition
Condition persistent atrial fibrillation
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To study the effect of Angiotensin II receptor blockers (ARB) in hypertensive patients with persistent atrial fibrillation who are planned to be treated with electrical defibrillation by comparing the changes in serum metabolome between ARB(Losartan) administration group and RAS inhibitor non-administration group. The association with inflammatory markers, P Wave Signal-Averaged Electrocardiogram, or recurrence of atrial fibrillation is also investigated.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Changes in serum metabolome
Key secondary outcomes hs-CRP
ANP,BNP
Changes in blood-pressure level
P Wave Signal-Averaged Electrocardiogram
Echocardiographic indices
Recurrence of atrial fibrillation


Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Losartan group
Interventions/Control_2 Non-RA inhibitor group
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) patients with persistent atrial fibrillation
2) Hypertensive patients
3) patients planned to be treated with electrical defibrillation
4) patients aged 20 years or older
5) patients who gave their written informed consent to participate

Key exclusion criteria 1) patients with poorly-controlled hypertension (DBP>120 mmHg)
2) patients with complications whose condition is unstable
3) patients with severe renal function impairment or hepatic function impairment
4) patients who are or may be pregnant or lactating
5) patients with a history of allergic reaction to the drug used in the study
6) patients with hyperkalemia
7) patients who are judged to be inappropriate for the entry into the study by the investigator
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Asumi Takei
Organization Kobe University Graduate School of Medicine
Division name Division of Cardiovascular Medicine
Zip code
Address 7-5-1,Kusunoki-Cho,Chuo-Ku,Kobe,650-0017 Japan
TEL 078-382-5846
Email

Public contact
Name of contact person
1st name
Middle name
Last name Asumi Takei
Organization Kobe University Graduate School of Medicine
Division name Division of Cardiovascular Medicine
Zip code
Address 7-5-1,Kusunoki-Cho,Chuo-Ku,Kobe,650-0017 Japan
TEL 078-382-5846
Homepage URL
Email asumit@med.kobe-u.ac.jp

Sponsor
Institute Kobe University
Institute
Department

Funding Source
Organization Kobe University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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 神戸大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2011 Year 06 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
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
2011 Year 04 Month 18 Day
Date of IRB
Anticipated trial start date
2011 Year 07 Month 01 Day
Last follow-up date
2014 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 05 Month 27 Day
Last modified on
2011 Year 05 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006698

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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