UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056772 |
|---|---|
| Receipt number | R000064896 |
| Scientific Title | A registry study for Lifestyle Habits and Physical Activity in patients with Atrial Fibrillation |
| Date of disclosure of the study information | 2025/02/01 |
| Last modified on | 2025/02/09 15:14:20 |
* 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
A registry study for Lifestyle Habits and Physical Activity in patients with Atrial Fibrillation
Acronym
ALPHA-AF
Scientific Title
A registry study for Lifestyle Habits and Physical Activity in patients with Atrial Fibrillation
Scientific Title:Acronym
A registry study for Lifestyle Habits and Physical Activity in patients with Atrial Fibrillation
Region
| Japan |
Condition
Condition
Atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Atrial fibrillation (AF) is a common arrhythmia, and in Japan, which is facing an aging society, the number of patients with AF was already estimated to be 716,000 as of 2005. In patients with AF, not only is there a decline in quality of life (QoL), but also an increased risk of thromboembolic events such as stroke, heart failure, and mortality. Catheter ablation, a percutaneous catheter myocardial ablation procedure, is the most effective treatment option for maintaining sinus rhythm. Advances in treatment devices, perioperative management improvements, and demonstrated benefits in QoL and prognosis have led to its expanded application.
However, the recurrence rate of AF within one year after ablation remains high, ranging from 18-43% for paroxysmal AF and 53% for persistent AF, indicating that the efficacy of ablation alone is limited. This is thought to be due, in part, to the progression of atrial degeneration, such as fibrosis and loss of myocardial cells, driven by aging, lifestyle factors, and comorbid conditions, which underlie the development of AF.
To maximize treatment efficacy, attention has been directed toward appropriate interventions targeting modifiable risk factors, such as exercise habits, alcohol consumption, sleep apnea, and blood pressure control. Recent studies have reported that interventions like exercise therapy and alcohol consumption reduction can improve outcomes after catheter ablation. However, the effectiveness of such interventions is influenced by patient preferences and treatment adherence and remains unclear for a highly heterogeneous patient population with varying degrees of arrhythmic substrate. This presents a clinical challenge in implementing appropriate interventions.
Basic objectives2
Others
Basic objectives -Others
This study aims to evaluate modifiable risk factors in patients undergoing catheter ablation for AF and to clarify how these factors are associated with electrophysiological findings during catheter ablation, post-treatment sinus rhythm maintenance rates, and symptom improvement. The ultimate goal is to enable more effective management and interventions for lifestyle habits and comorbidities in this patient population.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Recurrence of atrial tachyarrhythmias within three years after enrollment
Key secondary outcomes
Physical Activity: At 3 months and 12 months, symptoms, physical activity levels, and lifestyle habits will be assessed using a questionnaire (attached as Document 3). Additionally, accelerometer data recorded in the long-term Holter ECG will be collected.
Other Outcomes:
Mortality (overall mortality, cardiovascular death, and non-cardiovascular death)
Heart failure hospitalization (hospitalization due to exacerbation or new onset)
Stroke or systemic embolism
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
This study will include patients who meet all of the following criteria:
Aged 18 years or older at the time of consent.
Diagnosed with non-valvular atrial fibrillation and scheduled to undergo catheter ablation within three months.
Key exclusion criteria
1.Patients who have undergone catheter-based or surgical pulmonary vein isolation for atrial fibrillation.
2.Patients with diseases estimated to have a prognosis of less than one year.
3.Patients deemed unsuitable as study subjects by the investigator.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Shunsuke |
| Middle name | |
| Last name | Kuroda |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Cardiovascular Biology and Medicine
Zip code
113-0033
Address
3 Chome-1-3 Hongo, Bunkyo City, Tokyo
TEL
03-3813-3111
s.kuroda.qm@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Shunsuke |
| Middle name | |
| Last name | Kuroda |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Cardiovascular Biology and Medicine
Zip code
113-0033
Address
3 Chome-1-3 Hongo, Bunkyo City, Tokyo
TEL
03-3813-3111
Homepage URL
s.kuroda.qm@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
Research Ethics Committee Faculty of Medicine, Juntendo University
Address
3chome 1-3, Hongo, Bunkyo-ku, Tokyo
Tel
03-5802-1584
hongo-rinri@juntendo.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
| 2025 | Year | 02 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 12 | Month | 09 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 09 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2033 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a single-center cohort study involving the consecutive enrollment of patients who undergo their first atrial fibrillation ablation procedure at the study institution after the study approval date. Information on patient background, pre-treatment exercise tolerance, muscle mass, and lifestyle habits will be collected, and postoperative outcomes, including arrhythmia recurrence, exercise tolerance, and symptom improvement, will be tracked.
Management information
Registered date
| 2025 | Year | 01 | Month | 21 | Day |
Last modified on
| 2025 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064896
