UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031865 |
|---|---|
| Receipt number | R000036268 |
| Scientific Title | Effects of adrenomedullin in catheter ablation of persistent atrial fibrillation |
| Date of disclosure of the study information | 2022/01/01 |
| Last modified on | 2022/03/28 11:47:54 |
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Basic information
Public title
Effects of adrenomedullin in catheter ablation of persistent atrial fibrillation
Acronym
AM ablation
Scientific Title
Effects of adrenomedullin in catheter ablation of persistent atrial fibrillation
Scientific Title:Acronym
AM ablation
Region
| Japan |
Condition
Condition
persistent atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clarify the efficacy of adrenomedullin administration for preventing inflammation and atrial arrhythmia including atrial fibrillation immediately after catheter ablation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Cumulative time of atrial arrhythmia during 3 days after catheter ablation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
adrenomedullin administration (10 ng/kg/min, 8 hours per day, 5 days)
Interventions/Control_2
control (no intervention)
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. persistent atrial fibrillation over 6 months
2. consent to catheter ablation
3. consent to this study with consent forms
Key exclusion criteria
1. paroxysmal atrial fibrillation
2. valvular disease
3. heart diseases (heart failure, myocardial infarction, angina)
4. hyperthyroidism
5. left atrial with a diameter over 50 mm
6. evident infection or inflammatory disease
7. history of participation to study using adrenomedullin
8. untreated proliferative diabetic retinopathy
9. history of cardiovascular accident within 3 months
10. serious complications (renal insufficiency, liver damage, uncontrolled diabetes, uncontrolled hypertension)
11. malignancy or history of therapy for malignancy
12. pregnancy, lactating
13. other reason depend on the decision of investigator
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Kazuo |
| Middle name | |
| Last name | Kitamura |
Organization
University of Miyazaki, Faculty of Medicine
Division name
Division of Circulatory and body fluid regulation, Department of Internal Medicine
Zip code
889-1692
Address
Kihara 5200, Kiyotake, Miyazaki, Japan
TEL
0985-85-0872
kazuokit@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Toshihiro |
| Middle name | |
| Last name | Kita |
Organization
University of Miyazaki, Faculty of Medicine
Division name
Division of Circulatory and body fluid regulation, Department of Internal Medicine
Zip code
889-1692
Address
Kihara 5200, Kiyotake, Miyazaki, Japan
TEL
0985-85-0872
Homepage URL
toshihiro_kita@med.miyazaki-u.ac.jp
Sponsor or person
Institute
University of Miyazaki
Institute
Department
Personal name
Funding Source
Organization
University of Miyazaki
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
ethical committees of the University of Miyazaki
Address
Kihara 5200, Kiyotake, Miyazaki, Japan
Tel
0985-85-9403
rinken@med.miyazaki-u.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
None
Publication of results
Unpublished
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
7
Results
We enrolled 3 patients of adrenomedullin group and 4 patients of control group. Any statistically significant differences were not observed between adrenomedullin group and control group. We continued this study as Specified Clinical Research.
Results date posted
| 2022 | Year | 03 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with persistent atrial fibrillation that lasts for more than 6 months and who intend to receive catheter ablation in Miyazaki University Hospital
Participant flow
Patient who was matching selection criteria was allocated to adrenomedullin (AM) group or control group by online allocation system (open study). AM group were received 8 hours of continuous intravenous administration of AM for 5 days from the day before CA. Control group were received CA only. Atrial arrhythmia was monitored for 14 days after CA.
Adverse events
Adverse events that were caused by vasodilative effects of AM like hypotension and headache were concerned, but any events were not reported in this study.
Outcome measures
Primary endpoint; integrating time of atrial arrhythmia during 3 days after CA.
Secondary endpoint; 1. incidence of atrial arrhythmia during 3 days after CA, 2. incidence of atrial arrhythmia from 4 days after CA to 14 days, 3. changes of inflammation makers
Plan to share IPD
No
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2018 | Year | 03 | Month | 05 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 30 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 23 | Day |
Last modified on
| 2022 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036268
