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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029718
Receipt No. R000033944
Scientific Title Switching from adMinistration of lAndiolol to bisopRolol Transdermal PATCH for atrial tachyarrhythmia trial
Date of disclosure of the study information 2017/10/26
Last modified on 2017/10/26

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Basic information
Public title Switching from adMinistration of lAndiolol to bisopRolol Transdermal PATCH for atrial tachyarrhythmia trial
Acronym SMART-PATCH trial
Scientific Title Switching from adMinistration of lAndiolol to bisopRolol Transdermal PATCH for atrial tachyarrhythmia trial
Scientific Title:Acronym SMART-PATCH trial
Region
Japan

Condition
Condition atrial tachyarrhythmia in patients with reduced ejection fraction
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective of the study is to evaluate the safety of swtiching from administration of landiolol to bisoprolol transdermal patch, for patients with reduced ejection fraction.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1)Incidence of adverse event (death, lethal arrhythmia(ventricular tachycardia. ventricular fibrillation), prolongation of hospitalization, and complicaton that leaves sequelae) during the switching therapy.
2)Success rate of the switching therapy
Key secondary outcomes 1)The change of blood pressure and heart rate after switching therapy in 2 hours, 12 hours, 24 hours, and 48 hours.
2)The change of blood pressure and heart rate after landiolol administration in 2 hours and 24 hours.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 A bisoprolol patch (4 mg) was attached.
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 *Patients with sustained atrial fibrillation or flutter treated with continuous infusion of landiolol.
*Patients diagnosed with hypertension.
*Patients without increasing inotropic agent or oxygen administration within 2 hours before switching therapy.
*Patients of 20 years of age or older.
Key exclusion criteria *Patients with an left ventricular ejection fraction of 25-50%.
*Patients with systolic blood pressure 90 mmHg or less.
*Patients with severe aortic valve stenosis or severe mitral valve stenosis.
*Patients with contraindication to beta-blockers.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kneji Ando
Organization Kokura Memorial Hospital
Division name Department of Cardiology
Zip code
Address 3-2-1, Asano, Kokurakita-ku Kitakyushu, Fukuoka, Japan
TEL +81-93-511-2000
Email kmhptca@kokura-heart.com

Public contact
Name of contact person
1st name
Middle name
Last name Masato Fukunaga
Organization Kokura Memorial Hospital
Division name Department of Cardiology
Zip code
Address 3-2-1, Asano, Kokurakita-ku Kitakyushu, Fukuoka, Japan
TEL +81-93-511-2000
Homepage URL
Email masato_f0728@yahoo.co.jp

Sponsor
Institute Kokura Memorial Hospital
Institute
Department

Funding Source
Organization No funding source
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 平成紫川会 小倉記念病院 循環器内科

Other administrative information
Date of disclosure of the study information
2017 Year 10 Month 26 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 Preinitiation
Date of protocol fixation
2017 Year 10 Month 18 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 26 Day
Last follow-up date
2018 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 10 Month 26 Day
Last modified on
2017 Year 10 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033944

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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