UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005664 |
|---|---|
| Receipt number | 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 22:26:42 |
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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
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
asumit@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006698
