UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001941 |
|---|---|
| Receipt number | 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 16:45:44 |
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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
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
nojirit@thoracic.med.osaka-u.ac.jp
Sponsor or person
Institute
Toneyama National Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002362
