UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004342 |
|---|---|
| Receipt number | R000005198 |
| Scientific Title | The clinical research to evaluate the efficacy of landiolol on cardiac function in patients with acute heart failure |
| Date of disclosure of the study information | 2010/10/15 |
| Last modified on | 2011/04/20 09:42:29 |
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Basic information
Public title
The clinical research to evaluate the efficacy of landiolol on cardiac function in patients with acute heart failure
Acronym
Landiolol study
Scientific Title
The clinical research to evaluate the efficacy of landiolol on cardiac function in patients with acute heart failure
Scientific Title:Acronym
Landiolol study
Region
| Japan |
Condition
Condition
acute heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of landiolol on cardiac function in patients with acute heart failure
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1)To evaluate the effect of landiolol on hemodynamics by cardiac catherization
2)To investigate change of indeces of cardiac function by echocardiography
Key secondary outcomes
We recorded any adverse events that occurred during the administration of landiolol, such as hypotension (defined as systolic arterial pressure <60 mmHg), angina, electrocardiographic evidence of ischemia, acute renal failure, dyspnea, or arrhythmia. We also noted the clinical outcome for each patient.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) age:20-80 yaearts old
2)patients who admitted to CCU
3)EF<35%
4)HR>90bpm
5)NYHA III-IV
Key exclusion criteria
The exclusion criterion was a systolic blood pressure below 80 mmHg.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeki Kobayashi |
Organization
Yamaguchi University
Division name
Department of Medicine and Clinical Science
Zip code
Address
1-1-1 Minamikogushi, Ube, Yamaguchi 755-8505, Japan
TEL
0836-22-2248
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeki Kobayashi |
Organization
Yamaguchi University
Division name
Department of Medicine and Clinical Science
Zip code
Address
1-1-1 Minamikogushi, Ube, Yamaguchi 755-8505, Japan
TEL
0836-22-2248
Homepage URL
Sponsor or person
Institute
Department of Medicine and Clinical Science
Yamaguchi University
Institute
Department
Personal name
Funding Source
Organization
Department of Medicine and Clinical
Yamaguchi University
Organization
Division
Category of Funding Organization
Other
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
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 10 | Month | 15 | 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
Open public recruiting
Date of protocol fixation
| 2010 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 04 | 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
evaluation of cardiac function
Management information
Registered date
| 2010 | Year | 10 | Month | 06 | Day |
Last modified on
| 2011 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005198
