UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015053 |
|---|---|
| Receipt number | R000017515 |
| Scientific Title | Management of Rapid Heart Rate in Patients With Atrial Fibrillation/Flutter and Left Ventricular Dysfunction -Randomized Controlled Trial of Landiolol vs. Diltiazem- |
| Date of disclosure of the study information | 2014/09/15 |
| Last modified on | 2018/09/05 11:33:18 |
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Basic information
Public title
Management of Rapid Heart Rate in Patients With
Atrial Fibrillation/Flutter and Left Ventricular Dysfunction
-Randomized Controlled Trial of Landiolol vs. Diltiazem-
Acronym
Randomized Controlled Trial of Landiolol vs. Diltiazem
Scientific Title
Management of Rapid Heart Rate in Patients With
Atrial Fibrillation/Flutter and Left Ventricular Dysfunction
-Randomized Controlled Trial of Landiolol vs. Diltiazem-
Scientific Title:Acronym
Randomized Controlled Trial of Landiolol vs. Diltiazem
Region
| Japan |
Condition
Condition
Heart failure, Atrial Fibrillation/Flutter
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evalutation of safety and efficacy of therapeutic drugs
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary efficacy endpoint is the percentage of patients
with both a HR <110 beats/min and more than 20% decrease from
baseline at 2 h after administration.
The primary efficacy endpoint is the percentage of patients with severe hypotension, bradycardia.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Landiolol
Interventions/Control_2
Diltiazem
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
The main inclusion criteria were:
male or female inpatients aged more than 20 years; New York Heart
Association (NYHA) class III or IV; and AF/AFL with an LV
ejection fraction (EF) of 25 to 50% and more than 120 beats/min (HR).
Key exclusion criteria
The main exclusion criteria were: necessity for electrical cardioversion;
serious valve stenosis; confirmed or suspected hyperthyroidism;
implantable cardiac pacemaker and/or implantable
defibrillator; necessity for mechanical ventilation; and
cardiogenic shock (systolic blood pressure (BP) <90 mmHg).
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Tada |
Organization
Kurashiki Central Hospital
Division name
Cardiology
Zip code
Address
Miwa1-1-1, Kurashiki, Okayama
TEL
086-422-0210
yk13983@kchnet.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuichi Kawase |
Organization
Kurashiki Central Hospital
Division name
Cardiology
Zip code
Address
Miwa1-1-1, Kurashiki, Okayama
TEL
086-422-0210
Homepage URL
yk13983@kchnet.or.jp
Sponsor or person
Institute
Kurashiki Central Hospital
Institute
Department
Personal name
Funding Source
Organization
Kurashiki Central Hospital
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
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
| 2014 | Year | 09 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
Terminated
Date of protocol fixation
| 2014 | Year | 08 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 09 | Month | 04 | Day |
Last modified on
| 2018 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017515
