UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044669 |
|---|---|
| Receipt number | R000051012 |
| Scientific Title | To evaluate that catheter ablation of atrial fibrillation decrease serum uric acid level |
| Date of disclosure of the study information | 2021/06/28 |
| Last modified on | 2022/12/29 16:51:52 |
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Basic information
Public title
To evaluate that catheter ablation of atrial fibrillation decrease serum uric acid level
Acronym
Study of association between AF ablation and uric acid level
Scientific Title
To evaluate that catheter ablation of atrial fibrillation decrease serum uric acid level
Scientific Title:Acronym
Study of association between AF ablation and uric acid level
Region
| Japan |
Condition
Condition
Atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective was to explore that the catheter ablation for AF patients effects uric acid (UA), sugar and lipid metabolism and to reveal the association among these laboratory parameters.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Biomarkers of uric acid (UA), sugar and lipid metabolism after catheter ablation
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
AF patients who underwent initial AF ablation in our hospital between was included.
Key exclusion criteria
Patients with exchanging oral medicines for heart failure, hypertension, diabetes mellitus, dyslipidemia, and hyperuricemia drug during follow-up period, and those with receiving dialysis were excluded.
Target sample size
210
Research contact person
Name of lead principal investigator
| 1st name | Daisetsu |
| Middle name | |
| Last name | Aoyama |
Organization
University of Fukui
Division name
Department of Cardiovascular Medicine, Faculty of Medical Sciences
Zip code
910-1193
Address
23-3 Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui, Japan
TEL
0776618800
daisetsu@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | Daisetsu |
| Middle name | |
| Last name | Aoyama |
Organization
University of Fukui
Division name
Department of Cardiovascular Medicine, Faculty of Medical Sciences
Zip code
910-1193
Address
23-3 Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui, Japan
TEL
0776618800
Homepage URL
daisetsu@u-fukui.ac.jp
Sponsor or person
Institute
University of Fukui
Institute
Department
Personal name
Funding Source
Organization
No conflicts
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
University of Fukui
Address
23-3 Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui, Japan
Tel
0776618800
daisetsu@u-fukui.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
| 2021 | Year | 06 | Month | 28 | Day |
Related information
URL releasing protocol
chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/http://research.hosp.u-fukui.ac.jp/wp-content/up
Publication of results
Published
Result
URL related to results and publications
Heart and Vessels 2022 Dec;37(12):2049-2058. doi: 10.1007/s00380-022-02108-w.
Number of participants that the trial has enrolled
206
Results
Baseline BNP and UA levels significantly decreased at 1 year after ablation. Changes in UA level correlated significantly with pre-procedural UA level. Significant improvements in both persistent and paroxysmal AF patients were identified, and the magnitude of post-procedural serum UA level decline after ablation was significantly greater in patients with persistent AF than in those with paroxysmal AF.
Results date posted
| 2022 | Year | 12 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
This was a single-center, retrospective cohort analysis. Among 503 consecutive AF patients who underwent initial AF ablation in our hospital between September 2017 and July 2020, a total of 297 patients without follow-up data at < 1 year after the procedure, with recurrence of AF within 1 year after the procedure, with changes to oral medicines for heart failure, hypertension, diabetes mellitus, dyslipidemia, or hyperuricemia drugs during follow-up period, or who received dialysis were excluded. A final total of 206 patients was thus included in this study.
Participant flow
We continued in-hospital electrocardiographic monitoring for 3 to 5 days. No antiarrhythmic drugs were prescribed after the procedure except for patients with highly symptomatic early recurrence of AF. Regular follow-up consisted of outpatient clinic visits at 1 and 3 months after the procedure. Subsequent follow-up visits involved a clinical interview, 12 lead electrocardiogram, or 24h Holter electrocardiogram recordings every 3 months. Anticoagulation was continued for at least 3 months.
Adverse events
There were no adverse events due to this study because of retrospective cohort analysis.
Outcome measures
A total of 206 patients who underwent initial AF ablation without changes to oral medications were included. Baseline BNP and UA levels significantly decreased at 1 year after ablation (p < 0.05 each). Changes in UA level correlated significantly with pre-procedural UA level (r = 0.57). In multivariable logistic regression modeling, pre-procedural UA level, persistent AF, and hemoglobin A1c (p < 0.05 each) were independent predictors of post-procedural UA level decline. Significant improvements in both persistent and paroxysmal AF patients were identified, and the magnitude of post-procedural serum UA level decline after ablation was significantly greater in patients with persistent AF than in those with paroxysmal AF (p < 0.001). Of the 48 patients with high UA level before procedure, 28 patients showed improvement in UA level to normal range.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 06 | Month | 26 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 12 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 28 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study was a single-center, retrospective cohort analysis and AF patients who underwent initial AF ablation in our hospital between January 2011 and April 2021 was included.
Management information
Registered date
| 2021 | Year | 06 | Month | 26 | Day |
Last modified on
| 2022 | Year | 12 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051012
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