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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000004342 |
Receipt No. | 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 |
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 |
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Condition | ||
Condition | acute heart failure | |
Classification by specialty |
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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 |
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Age-upper limit |
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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 |
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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 |
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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 |
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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 | |
Institute | Department of Medicine and Clinical Science
Yamaguchi University |
Institute | |
Department |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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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
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Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005198 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |