UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Management of Rapid Heart Rate in Patients With Atrial Fibrillation/Flutter and Left Ventricular Dysfunction -Randomized Controlled Trial of Landiolol vs. Diltiazem-
Title of the study (Brief title)	Randomized Controlled Trial of Landiolol vs. Diltiazem
Region	Japan

Condition
Condition	Heart failure, Atrial Fibrillation/Flutter
Classification by specialty	Medicine in general Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evalutation of safety and efficacy of therapeutic drugs
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The primary efficacy endpoint is the percentage of patients with both a HR <110 beats/min and more than 20% decrease from baseline at 2 h after administration. The primary efficacy endpoint is the percentage of patients with severe hypotension, bradycardia.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Landiolol
Interventions/Control_2	Diltiazem
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	The main inclusion criteria were: male or female inpatients aged more than 20 years; New York Heart Association (NYHA) class III or IV; and AF/AFL with an LV ejection fraction (EF) of 25 to 50% and more than 120 beats/min (HR).
Key exclusion criteria	The main exclusion criteria were: necessity for electrical cardioversion; serious valve stenosis; confirmed or suspected hyperthyroidism; implantable cardiac pacemaker and/or implantable defibrillator; necessity for mechanical ventilation; and cardiogenic shock (systolic blood pressure (BP) <90 mmHg).
Target sample size	60

Research contact person
Name of lead principal investigator	Takeshi Tada
Organization	Kurashiki Central Hospital
Division name	Cardiology
Address	Miwa1-1-1, Kurashiki, Okayama
TEL	086-422-0210
Email	yk13983@kchnet.or.jp

Public contact
Name of contact person	Yuichi Kawase
Organization	Kurashiki Central Hospital
Division name	Cardiology
Address	Miwa1-1-1, Kurashiki, Okayama
TEL	086-422-0210
Homepage URL
Email	yk13983@kchnet.or.jp

Sponsor
Institute	Kurashiki Central Hospital
Institute
Department

Funding Source
Organization	Kurashiki Central Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information	2014 Year 09 Month 15 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 08 Month 25 Day
Anticipated trial start date	2014 Year 09 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 09 Month 04 Day
Last modified on	2018 Year 09 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017515