UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062893 |
|---|---|
| Receipt number | R000072014 |
| Scientific Title | HFA-PEFF-Defined HFpEF Phenotype and Cardiac Remodeling With and Without Atrial Fibrillation Ablation |
| Date of disclosure of the study information | 2026/09/12 |
| Last modified on | 2026/09/12 12:56:11 |
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Basic information
Public title
HFA-PEFF-Defined HFpEF Phenotype and Cardiac Remodeling With and Without Atrial Fibrillation Ablation
Acronym
SAKURA-AF2 Study
Scientific Title
HFA-PEFF-Defined HFpEF Phenotype and Cardiac Remodeling With and Without Atrial Fibrillation Ablation
Scientific Title:Acronym
SAKURA-AF2 Study
Region
| Japan |
Condition
Condition
Nonvalvular atrial fibrillation with left ventricular ejection fraction >=40%
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the prevalence and prognosis of the HFA-PEFF-defined HFpEF phenotype in patients with nonvalvular atrial fibrillation and a left ventricular ejection fraction of 40% or greater. We also aim to compare 1-year changes in HFA-PEFF scores and cardiac remodeling between patients with and without catheter ablation and to explore their associations with clinical outcomes.
Basic objectives2
Others
Basic objectives -Others
Evaluation of HFpEF prevalence and prognosis and longitudinal changes in cardiac remodeling
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
cardiovascular death or worsening heart failure during the 1-year follow-up period
Key secondary outcomes
The key secondary outcome is a composite of stroke, systemic embolism, or myocardial infarction during the 1-year follow-up period. The safety outcome is a bleeding event, defined as major bleeding according to the ISTH criteria or clinically relevant non-major bleeding. A net clinical outcome comprising all-cause death, worsening heart failure, stroke, systemic embolism, myocardial infarction, or bleeding events, as well as its individual components, will also be evaluated. Other secondary outcomes include transient ischemic attack, unstable angina, other cardiovascular events requiring hospitalization, cardiovascular death, sudden death, other causes of death, recurrence of atrial fibrillation after catheter ablation, pacemaker implantation, falls, fractures, pneumonia, and newly diagnosed cancer. Changes from baseline to 1 year in body weight, symptoms, Clinical Frailty Scale, Specific Activity Scale, exercise activity, laboratory and nutritional indices, medications, HFA-PEFF score, H2FPEF score, echocardiographic parameters, and cardiac remodeling parameters will also be assessed. Changes in the HFA-PEFF score and its individual domains and cardiac remodeling parameters will be compared between patients with and without catheter ablation.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients aged 20 years or older with nonvalvular atrial fibrillation
2. Patients undergoing regular outpatient follow-up
3. Left ventricular ejection fraction greater than 40%
4. Written informed consent to participate in the study
Key exclusion criteria
1. Severe frailty defined as a Clinical Frailty Scale score of 8 or higher
2. Severe valvular heart disease
3. Active malignancy
4. Patients considered inappropriate for participation by the principal investigator or study investigators
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | Yasuo |
| Middle name | |
| Last name | Okumura |
Organization
Nihon University School of Medicine
Division name
Division of Cardiology
Zip code
173-8610
Address
30-1 Oyaguchi-kamicho, Itabashi-ku, Tokyo 173-8610, Japan
TEL
03-3972-8111
okumura.yasuo@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Toshiki |
| Middle name | |
| Last name | Setoguchi |
Organization
Nihon University Hospital
Division name
Department of Cardiology
Zip code
101-8309
Address
1-6 Kanda-Surugadai, Chiyoda-ku, Tokyo 101-8309, Japan
TEL
03-3293-1711
Homepage URL
setoguchi.toshiki@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University
Institute
Department
Personal name
Yasuo Okumura
Funding Source
Organization
Nihon University
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
Nihon University Hospital Clinical Research Review Committee
Address
1-6 Kanda-Surugadai, Chiyoda-ku, Tokyo 101-8309, Japan
Tel
03-3293-1711
kotani.yasuyuki@nihon-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
日本大学病院（東京都）
日本大学医学部附属板橋病院（東京都）
川口市立医療センター（埼玉県）
横浜中央病院（神奈川県）
TMGあさか医療センター（埼玉県）
春日部市立医療センター（埼玉県）
東京臨海病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 12 | 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
485
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 02 | Month | 03 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 14 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 26 | Day |
Last follow-up date
| 2026 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a prospective multicenter observational study of patients with nonvalvular atrial fibrillation and a left ventricular ejection fraction of 40% or greater. No study-specific intervention or treatment allocation is performed. Clinical data are collected from medical records at baseline and 1 year, including patient characteristics, laboratory findings, medications, echocardiographic parameters, HFA-PEFF scores, catheter ablation status, and clinical outcomes. The study evaluates the prevalence and prognosis of the HFA-PEFF-defined HFpEF phenotype and compares 1-year changes in HFA-PEFF scores and cardiac remodeling between patients with and without catheter ablation.
Management information
Registered date
| 2026 | Year | 09 | Month | 12 | Day |
Last modified on
| 2026 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072014
