UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001848 |
|---|---|
| Receipt number | R000002222 |
| Scientific Title | The study of the usefulness of beta-blocker for hypertensive patients with persistent atrial fibrillation combined with reduced cardiac function |
| Date of disclosure of the study information | 2009/04/04 |
| Last modified on | 2015/11/05 09:35:46 |
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Basic information
Public title
The study of the usefulness of beta-blocker for hypertensive patients with persistent atrial fibrillation combined with reduced cardiac function
Acronym
The study of the usefulness of beta-blocker for hypertensive patients with persistent atrial fibrillation combined with reduced cardiac function
Scientific Title
The study of the usefulness of beta-blocker for hypertensive patients with persistent atrial fibrillation combined with reduced cardiac function
Scientific Title:Acronym
The study of the usefulness of beta-blocker for hypertensive patients with persistent atrial fibrillation combined with reduced cardiac function
Region
| Japan |
Condition
Condition
hypertensive patients with persistent atrial fibrillation combined with reduced cardiac function
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is making a comparative consideration of the effect of beta-blocker for hypertensive patients with persistent atrial fibrillation combined with reduced cardiac function, especially for heart rate control.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Subjective symptom: Frequency of palpitation
2. Objective symptom: New York Heart Association (NYHA) classification of cardiac performance, BP, HR
3. Laboratory test: Blood biochemical findings include BNP, NT-proBNP, Urinalysis
4. Physiological laboratory: ambulatory electrocardiography, cardiac ultrasonography
5. Adverse event
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
Changing of beta-blocker
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 with an inadequate heart rate control with carvedilol administration over one month
Key exclusion criteria
Patients with class III or IV of NYHA classification
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Kunimoto |
Organization
Nihon University school of medicine
Division name
Division of cardiology, Department of medicine
Zip code
Address
30-1, Oyagushi Kami-cho, Itanashiku, Tokyo, 1738610 JAPAN
TEL
03-3972-8111
kunimoto.satoshi@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Kunimoto |
Organization
Nihon University School of Medicine
Division name
Division of cardiology, Department of medicine
Zip code
Address
30-1, Oyagushi Kami-cho, Itanashiku, Tokyo, 1738610 JAPAN
TEL
03-3972-8111
Homepage URL
kunimoto@med.nihon-u.ac.jp
Sponsor or person
Institute
Nihon University School of Medicine
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
none
Name of secondary funder(s)
none
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
日本大学医学部附属板橋病院
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 04 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Open public recruiting
Date of protocol fixation
| 2009 | Year | 03 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | 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
| 2009 | Year | 04 | Month | 04 | Day |
Last modified on
| 2015 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002222
