UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006343 |
|---|---|
| Receipt number | R000007512 |
| Scientific Title | Assessment of Atrial Late Potentials in Patients with Hypertention to Investigate the Preventive Effect of Eplerenone on Atrial Fibrillation. |
| Date of disclosure of the study information | 2011/10/01 |
| Last modified on | 2015/03/15 14:51:53 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Assessment of Atrial Late Potentials in Patients with Hypertention
to Investigate the Preventive Effect of Eplerenone on Atrial Fibrillation.
Acronym
Assessment of Atrial Late Potentials in Patients with Hypertention
to Investigate the Preventive Effect of Eplerenone on Atrial Fibrillation.
Scientific Title
Assessment of Atrial Late Potentials in Patients with Hypertention
to Investigate the Preventive Effect of Eplerenone on Atrial Fibrillation.
Scientific Title:Acronym
Assessment of Atrial Late Potentials in Patients with Hypertention
to Investigate the Preventive Effect of Eplerenone on Atrial Fibrillation.
Region
| Japan |
Condition
Condition
Hypertention
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objectives of this study are to evaluate the protective effect of eplerenone on the substrate of atrial fibrillation, using P wave signal-averaged ECG.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Change in atrial late potentials recorded by P wave signal-averaged ECG.
Key secondary outcomes
1. Correlation between baseline characteristics and atrial late potentials.
2. Correlation between change in atrial late potentials and change in blood biomarkers.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Eplerenone 25-100 mg daily for a period of 12 months
Interventions/Control_2
Non-renin angiotensin aldosteron system blocker treatment initially using amlodipine 5 mg daily for a period of 12 months
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
1. Patients with hypertention who have not attained the target blood pressure level established by the Japan Society of hypertention 2009 guidelines.
2. Patients giving written consent on their own volition for participation in this clinical trial after being provided with sufficient explanation about the study.
Key exclusion criteria
1. Patients who have a contraindication to Selara TAB administration.
2. Patients who have a contraindication to Norvasc TAB administration .
3. Patients with liver dysfunction (AST or ALT values of >=100IU).
4. Patients who are judged by the investigator to be not eligible for enrollment in the study.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masato Kawasaki |
Organization
Osaka General Medical Center
Division name
Division of Cardiology
Zip code
Address
3-1-56 Bandai-Higashi, Sumiyoshi-ku, Osaka, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masato Kawasaki |
Organization
Osaka General Medical Center
Division name
Division of Cardiology
Zip code
Address
TEL
Homepage URL
bpbhm701@yahoo.co.jp
Sponsor or person
Institute
Osaka General Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
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
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
大阪府立急性期・総合医療センター
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 10 | 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
Completed
Date of protocol fixation
| 2011 | Year | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 09 | Month | 14 | Day |
Last modified on
| 2015 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007512
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
