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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000004607
Receipt No. R000005470
Scientific Title The effect of Irbesartan for cardiac function in patients with atrial fibrillation
Date of disclosure of the study information 2010/11/23
Last modified on 2012/08/14

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Basic information
Public title The effect of Irbesartan for cardiac function in patients with atrial fibrillation
Acronym Irbesartan af study
Scientific Title The effect of Irbesartan for cardiac function in patients with atrial fibrillation
Scientific Title:Acronym Irbesartan af study
Region
Japan

Condition
Condition Patients with hypertension and atrial fibrillation
Classification by specialty
Cardiology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the effective of Irbesartan in hypertensive patient with atrial fibrillation
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Influence on blood pressure and cardiac function
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 The 100mg of Irbesartan will be administered to the hypertensive patients with atrial fibrillation
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. Hypertensive patients of outpatient clinic
2. Patients with atrial fibrillation
3. Patients who is not taking ARB
4. Patients who receive approval about this study after taking enough explanation
Key exclusion criteria 1. Patients with renal failure
2. Patients who have severe infection and malignancy
3. Immunocompromised patients
4. Patients who are pregnant or hope for pregnancy
5. Patients who are judged inappropriate for the study by the attending physician
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akihiro Hayashida
Organization Kawasaki medical school
Division name Cardiology
Zip code
Address 577 Matsushima Kurashiki Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Division of cardiology
Division name Division of cardiology
Zip code
Address
TEL
Homepage URL
Email h-aki@msc.biglobe.ne.jp

Sponsor
Institute Kawasaki medical school, Division of cardiology
Institute
Department

Funding Source
Organization Kawasaki medical school, Division of cardiology
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
2010 Year 11 Month 23 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 No longer recruiting
Date of protocol fixation
2010 Year 11 Month 23 Day
Date of IRB
Anticipated trial start date
2010 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 11 Month 23 Day
Last modified on
2012 Year 08 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005470

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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