UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of landiolol on rehospitalization for heart failure in patients with acute heart failure and atrial fibrillation
Title of the study (Brief title)	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	Yuko Kato
Organization	The Cardiovascular Institute
Division name	The Department of Cardiovascular Medicine
Address	3-2-19, Nishi-azabu, Minatoku, Tokyo
TEL	03-3408-2151
Email	y-katou@cvi.or.jp

Public contact
Name of contact person	Kazumi Matsuda
Organization	The Cardiovascular Institute
Division name	Head Office
Address	3-2-19, Nishiazabu, Minatoku, Tokyo
TEL	03-3408-2151
Homepage URL	http://www.cvi.or.jp/
Email	matsuda@cvi.or.jp

Sponsor
Institute	The Cardiovascular Institute
Institute
Department

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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2015 Year 07 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020641