UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033650
Receipt number 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 21:01:43

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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 or person

Institute

Tokyo Women's Medical University

Institute

Department

Personal name



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

Value
https://center6.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