UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020290 |
|---|---|
| Receipt number | R000020641 |
| Scientific Title | The effect of landiolol on rehospitalization for heart failure in patients with acute heart failure and atrial fibrillation |
| Date of disclosure of the study information | 2015/12/28 |
| Last modified on | 2018/12/28 15:10:59 |
* 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
The effect of landiolol on rehospitalization for heart failure in patients with acute heart failure and atrial fibrillation
Acronym
The effect of landiolol on rehospitalization for heart failure in patients with acute heart failure and atrial fibrillation
Scientific Title
The effect of landiolol on rehospitalization for heart failure in patients with acute heart failure and atrial fibrillation
Scientific Title:Acronym
The effect of landiolol on rehospitalization for heart failure in patients with acute heart failure and atrial fibrillation
Region
| Japan |
Condition
Condition
Acute heart failure with tachycardic atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of landiolol on prognosis for heart failure
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Rehospitalization for heart failure and cardiovascular death within 6 months after administration of landiolol
Key secondary outcomes
The effect of landiolol administration to cardiac function, sympathetic activity of heart and BNP value
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
2 days administration of landiolol after hospitalization for acute heart failure
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
Left ventricular ejection fraction more than 25%
NYHA 3-4
Heart rate more than 120 bpm.
Key exclusion criteria
1)Taking any oral beta-blocker
2)Patients required electronic shock
3)Severe valve stenosis
4)Acute coronary syndrome
5)Hyperthyroidism or its prospects
6)Hypotension less than 100mmHg
7)Pacemaker implanted or ICD implanted
8)Under respirator
9)Cardiogenic shock
10)Assessed as not being suitable for applicants
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuko Kato |
Organization
The Cardiovascular Institute
Division name
The Department of Cardiovascular Medicine
Zip code
Address
3-2-19, Nishi-azabu, Minatoku, Tokyo
TEL
03-3408-2151
y-katou@cvi.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazumi Matsuda |
Organization
The Cardiovascular Institute
Division name
Head Office
Zip code
Address
3-2-19, Nishiazabu, Minatoku, Tokyo
TEL
03-3408-2151
Homepage URL
http://www.cvi.or.jp/
matsuda@cvi.or.jp
Sponsor or person
Institute
The Cardiovascular Institute
Institute
Department
Personal name
Funding Source
Organization
Ono Pharmaceutical Co.
Organization
Division
Category of Funding Organization
Other
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
心臓血管研究所付属病院（東京都）/The Cardiovascular Institute Hospital
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 28 | 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
| 2015 | Year | 07 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2018 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 04 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 21 | Day |
Last modified on
| 2018 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020641
