UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053787 |
|---|---|
| Receipt number | R000061344 |
| Scientific Title | Pilot Study on the Efficacy and Safety of Nifekalant Cocktail for Atrial Flutter |
| Date of disclosure of the study information | 2024/03/07 |
| Last modified on | 2024/03/06 11:24:18 |
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Basic information
Public title
Pilot Study on the Efficacy and Safety of Nifekalant Cocktail for Atrial Flutter
Acronym
Nifekalant Cocktail for Atrial Flutter
Scientific Title
Pilot Study on the Efficacy and Safety of Nifekalant Cocktail for Atrial Flutter
Scientific Title:Acronym
Pilot Study on the Efficacy and Safety of Nifekalant Cocktail for Atrial Flutter
Region
| Japan |
Condition
Condition
Atrial flutter
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
While Nifekalant isn't officially indicated for atrial flutter, Japanese guidelines recommend its use for this condition. Consequently, it's often administered in clinical practice for atrial flutter. However, due to its significant side effect of QT prolongation, which can lead to a life-threatening ventricular arrhythmia called torsade de pointes, careful consideration is required when prescribing it. Magnesium sulfate is known to be highly effective for the prevention and treatment of torsade de pointes. Based on these insights, we hypothesized that a combined administration of Nifekalant and magnesium sulfate (a Nifekalant Cocktail) could safely terminate atrial flutter. This study aims to prove that hypothesis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary effective outcome: termination of atrial flutter
Primary safety outcome: adverse effects including Torsade de pointes
Key secondary outcomes
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
In patients with atrial flutter, administer 2g of magnesium sulfate via intravenous infusion over a period of 15 minutes, followed by an intravenous administration of 0.3mg/kg of Nifekalant over 5 minutes.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients presenting with persistent symptomatic atrial flutter at the time of evaluation.
Key exclusion criteria
Individuals exhibiting any of the following conditions:
1. QTc interval >=470 msec
2. Advanced atrioventricular block
3. Systolic blood pressure <90 mmHg
4. eGFR <15 mL/min/1.73m2
5. Severe hepatic impairment
6. Intracardiac thrombus
7. Pregnancy
8. Lack of consent to participate in the study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Akinori |
| Middle name | |
| Last name | Sairaku |
Organization
National Hospital Organization Higashihiroshima Medical Center
Division name
Cardiology
Zip code
739-0041
Address
513 Jike, Saijo-cho, Higashihiroshima
TEL
082-423-2176
rjrgw059@ybb.ne.jp
Public contact
Name of contact person
| 1st name | Akinori |
| Middle name | |
| Last name | Sairaku |
Organization
National Hospital Organization Higashihiroshima Medical Center
Division name
Cardiology
Zip code
739-0041
Address
513 Jike, Saijo-cho, Higashihiroshima
TEL
082-423-2176
Homepage URL
rjrgw059@ybb.ne.jp
Sponsor or person
Institute
National Hospital Organization Higashihiroshima Medical Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Higashihiroshima Medical Center
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
Institutional Review Board of Onomichi General Hospital
Address
1-10-23 Hirahara, Onomichi
Tel
0848-22-8111
e.asami@hirokouren.or.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
OJH-202153
Org. issuing International ID_1
Institutional Review Board of Onomichi General Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 03 | Month | 07 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 20 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 21 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 03 | Month | 06 | Day |
Last modified on
| 2024 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061344
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
