UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020084 |
|---|---|
| Receipt number | R000023203 |
| Scientific Title | The Usefulness and Hemodynamic Effect of Landiolol Treatment to Control Atrial Tachyarrhythmia in Patients with Heart Failure with Reduced Ejection Fraction in The Acute Phase |
| Date of disclosure of the study information | 2015/12/07 |
| Last modified on | 2023/06/15 23:58:35 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The Usefulness and Hemodynamic Effect of Landiolol Treatment to Control Atrial Tachyarrhythmia in Patients with Heart Failure with Reduced Ejection Fraction in The Acute Phase
Acronym
Landiolol for ADHF with HFrEF
Scientific Title
The Usefulness and Hemodynamic Effect of Landiolol Treatment to Control Atrial Tachyarrhythmia in Patients with Heart Failure with Reduced Ejection Fraction in The Acute Phase
Scientific Title:Acronym
Landiolol for ADHF with HFrEF
Region
| Japan |
Condition
Condition
The patients with heart failure with reduced ejection fraction(EF<40%) who have rapid atrial tachyarrhythmia in the acute phase of acute decompensated heart failure.
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We explore the usefulness and impact of hemodynamic effect of Lnadiolol treatment to control the heart rate in patients with reduced ejection fraction in the acute phase of acute decompensated heart failure. We explore these effects using not only echocardiography but also pulmonary arterial catheterization. Furthermore, we check the medical record in order to get the information of clinical data such as heart rate, blood pressure and biochemical data. If possible, we follow the patients to seek their prognosis and examine the role of HR control by landiolol.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Heart rate reduction and hemodynamic improvements
Key secondary outcomes
Safety
Prognosis and examine the role of HR reduction on the prognosis.
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
To control HR of rapid AF by landiolol in ptients with ADHF.To uptitrate landiolol by the effectiveness of HR reduction and hemodynamic improvement.
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
1.LVEF<40%
2.atrial tachyarrhtthmia with HR >120/min
3.being with Lnadiolol treatment
Key exclusion criteria
1.extremely hemodynamically disruption
2.no standard treatment for heart failure
3.excess dehydration or abnormal electrolysis without any appropriate treatment
4.systolic blood pressure <80mmHg
5.apparent cardiogenic shock
6.pregnant
7.thyroid or adrenal disease
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Noriaki |
| Middle name | |
| Last name | Iwahashi |
Organization
Yokohama City University Medical Center
Division name
Division of Cardiology
Zip code
232-0024
Address
4-57 Urafune-cho Minami-ku Yokohama City
TEL
045-261-5656
wsnorikun@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Noriaki |
| Middle name | |
| Last name | Iwahashi |
Organization
Yokohama City University Medical Center
Division name
Diision of Cardiology
Zip code
232-0024
Address
4-57 Urafune-cho Minami-ku Yokohama City
TEL
045-261-5656
Homepage URL
wsnorikun@yahoo.co.jp
Sponsor or person
Institute
Yokohama City University Medical Center
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University Medical Center
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
Canliovascular nter Yokohama City University Medical Center
Address
4-57 Urafunbe-cho Minami-ku Yokohama
Tel
045-370-7627
rinri@yokohama-cu.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
横浜市立大学付属市民総合医療センター
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 07 | Day |
Related information
URL releasing protocol
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7897576/
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7897576/
Number of participants that the trial has enrolled
115
Results
Circ Rep. 2019 Sep 26;1(10):422-430. doi: 10.1253/circrep.CR-19-0076.
J Cardiol. 2022 Jan;79(1):21-29. doi: 10.1016/j.jjcc.2021.09.008. Epub 2021 Sep 2
Results date posted
| 2023 | Year | 06 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7897576/
Participant flow
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7897576/
Adverse events
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7897576/
Outcome measures
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7897576/
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2013 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We have been checking the status of patients using echocardiography and PA catheterization.
We have already published the paper about some of this study.
Management information
Registered date
| 2015 | Year | 12 | Month | 05 | Day |
Last modified on
| 2023 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023203
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
