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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033650
Receipt No. R000038365
Scientific Title Observational study on the effiacy of landiolol for the treatment of atrial tachyarrhythmias and predictor of outcome
Date of disclosure of the study information 2018/08/07
Last modified on 2019/08/07

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Basic information
Public title Observational study on the effiacy of landiolol for the treatment of atrial tachyarrhythmias and predictor of outcome
Acronym Landiolol in atrial tachyarrhythmias
Scientific Title Observational study on the effiacy of landiolol for the treatment of atrial tachyarrhythmias and predictor of outcome
Scientific Title:Acronym Landiolol in atrial tachyarrhythmias
Region
Japan

Condition
Condition atrial tachyarrhythmias
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the theraputic effect of intravenous landiolol and outcome in patients with atrial tachyarrhythmias and heart failure.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Heart rate and blood pressure during intravenous infusion of landiolol
Key secondary outcomes Restoration of sinus rhythm
Left ventricular ejection fraction
Plasma BNP
Total death
Hospitalization due to worsening heart failure

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
18 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria Patients who underwent continuous intravenous infusion of raniorolol for the treatment of atrial tachyarrhythmias
Key exclusion criteria Patients that are ineligible for this study (such as lack of information)
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Nobuhisa
Middle name
Last name Hagiwara
Organization Tokyo Women's Medical University
Division name Department of Cardiology
Zip code 162-8666
Address 8-1 Kawada-cho, Shinjuku-ku, Tokyo 162-8666, Japan
TEL 03-3353-8111
Email hagiwara.nobuhisa@twmu.ac.jp

Public contact
Name of contact person
1st name Tsuyoshi
Middle name
Last name Shiga
Organization Tokyo Women's Medical University
Division name Department of Cardiology
Zip code 162-8666
Address 8-1 Kawada-cho, Shinjuku-ku, Tokyo 162-8666, Japan
TEL 03-3353-8111
Homepage URL
Email shiga.tsuyoshi@twmu.ac.jp

Sponsor
Institute Tokyo Women's Medical University
Institute
Department

Funding Source
Organization Self-sourcing
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization The Institutional Review Board of Tokyo Womens Medical University
Address 8-1 Kawada-cho, Shinjuku-ku, Tokyo 162-8666, Japan
Tel 03-3353-8111
Email krinri.bm@twmu.ac.jp

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 東京女子医科大学病院(東京都)

Other administrative information
Date of disclosure of the study information
2018 Year 08 Month 07 Day

Related information
URL releasing protocol https://link.springer.com/content/pdf/10.1007%2Fs40801-019-0149-1.pdf
Publication of results Published

Result
URL related to results and publications https://link.springer.com/content/pdf/10.1007%2Fs40801-019-0149-1.pdf
Number of participants that the trial has enrolled 67
Results The median maintenance dose of intravenous landiolol was 3.0 microg/kg/min. Intravenous landiolol reduced the heart rate without a marked reduction in blood pressure. During landiolol treatment, 15 (22%) patients had spontaneously restored sinus rhythm. Eight patients experienced in-hospital death, and 41(69%) were discharged with sinus rhythm. During the follow-up of 16 months, patients with sinus rhythm showed a lower frequency of rehospitalization due to HF than patients with ATAs (5/41 vs 7/18).
Results date posted
2019 Year 08 Month 07 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics Total 67 consecutive patients with atrial tachyarrhythmias who were admitted to our hospital due to worsening heart failure from May 2014 to December 2017 at Tokyo Women's Medical University Hospital
Participant flow All patients were included.
Adverse events Landiolol treatment was discontinued in 3 patients because of the following adverse effects: hypotension(<90mmHg) in 2 patients and liver dysfunction in 1 patient.
Outcome measures The primary endpoints were changes in heart rate and systolic blood pressure from baseline during intravenous landiolol administration. The secondary endpoints included the restoration of sinus rhythm and outcomes.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 09 Month 21 Day
Date of IRB
2018 Year 02 Month 09 Day
Anticipated trial start date
2014 Year 05 Month 01 Day
Last follow-up date
2017 Year 12 Month 31 Day
Date of closure to data entry
2018 Year 09 Month 01 Day
Date trial data considered complete
2018 Year 10 Month 07 Day
Date analysis concluded
2018 Year 10 Month 12 Day

Other
Other related information Total 67 consecutive patients with atrial tachyarrhythmias who were admitted to our hospital due to worsening heart failure from May 2014 to December 2017 at Tokyo Women's Medical University Hospital were retrospectively included in this analysis.

Management information
Registered date
2018 Year 08 Month 06 Day
Last modified on
2019 Year 08 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038365

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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