UMIN-CTR Clinical Trial

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
Email

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
Email

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
Email

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
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

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