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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001941
Receipt No. R000002362
Scientific Title Efficacy of Low-dose Landiolol and carvedilol in Patients with Supraventricular Tachycardia after Pulmonary Resections
Date of disclosure of the study information 2009/05/05
Last modified on 2012/06/06

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Basic information
Public title Efficacy of Low-dose Landiolol and carvedilol in Patients with Supraventricular Tachycardia after Pulmonary Resections
Acronym Efficacy of Landiolol in Patients with Arrhythmias after Pulmonary Resections
Scientific Title Efficacy of Low-dose Landiolol and carvedilol in Patients with Supraventricular Tachycardia after Pulmonary Resections
Scientific Title:Acronym Efficacy of Landiolol in Patients with Arrhythmias after Pulmonary Resections
Region
Japan

Condition
Condition Lung Cancer
Classification by specialty
Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of low-dose landiolol and carvedilol in patients with supraventricular tachycardia after pulmonary resections for lung cancer
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Control of Heart Rate
Key secondary outcomes Safety (Hemodynamics)

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Landiolol Group
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with supraventricular tachycardia after pulmonary resections for lung cancer
Key exclusion criteria None
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Nojiri
Organization Toneyama National Hospital
Division name General Thoracic Surgery
Zip code
Address Toneyama 5-1-1, Toyonaka City, Osaka
TEL 06-6853-2001
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Nojiri
Organization Toneyama National Hospital
Division name General Thoracic Surgery
Zip code
Address Toneyama 5-1-1, Toyonaka City, Osaka
TEL 06-6853-2001
Homepage URL
Email nojirit@thoracic.med.osaka-u.ac.jp

Sponsor
Institute Toneyama National Hospital
Institute
Department

Funding Source
Organization None
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
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

Other administrative information
Date of disclosure of the study information
2009 Year 05 Month 05 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/22173677
Number of participants that the trial has enrolled
Results
RESULTS; 
There were no significant differences between the two groups regarding blood pressure before and after medication. Heart rate was reduced immediately in both groups after medication and was significantly lower in the landiolol group than in the control group. The time to restore sinus rhythm was significantly shorter in the landiolol group than in the control group. In none of the subjects with the landiolol infusion was it discontinued because of side effects.
CONCLUSION; 
Low-dose landiolol can be effective quickly and used safely in patients who develop atrial fibrillation after pulmonary resection for lung cancer.
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 Completed
Date of protocol fixation
2007 Year 07 Month 05 Day
Date of IRB
Anticipated trial start date
2008 Year 01 Month 01 Day
Last follow-up date
2010 Year 10 Month 01 Day
Date of closure to data entry
2010 Year 10 Month 01 Day
Date trial data considered complete
2011 Year 03 Month 01 Day
Date analysis concluded
2011 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 05 Month 05 Day
Last modified on
2012 Year 06 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002362

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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