UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062102 |
|---|---|
| Receipt number | R000071060 |
| Scientific Title | Association Between Reverse Remodeling and Electrocardiogram Normalization in Heart Failure with Reduced Ejection Fraction: A Multicenter Retrospective Cohort Study |
| Date of disclosure of the study information | 2026/07/01 |
| Last modified on | 2026/06/30 15:47:18 |
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Basic information
Public title
Association Between Reverse Remodeling and Electrocardiogram Normalization in Heart Failure with Reduced Ejection Fraction
Acronym
ARREN-HF
Scientific Title
Association Between Reverse Remodeling and Electrocardiogram Normalization in Heart Failure with Reduced Ejection Fraction: A Multicenter Retrospective Cohort Study
Scientific Title:Acronym
ARREN-HF
Region
| Japan |
Condition
Condition
Heart failure with reduced ejection fraction
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the association between normalization or persistence of abnormalities on 12-lead electrocardiography at the time of left ventricular ejection fraction improvement and subsequent heart failure worsening events and death among patients with heart failure with reduced ejection fraction who experienced reverse remodeling. This study aims to identify electrocardiographic findings useful for risk stratification after reverse remodeling.
Basic objectives2
Others
Basic objectives -Others
Prognostic assessment and risk stratification
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Heart failure worsening events after reverse remodeling
Key secondary outcomes
Death after reverse remodeling; composite endpoint of heart failure worsening events or death after reverse remodeling; electrocardiographic findings before reverse remodeling
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
Patients who visited the Department of Cardiology at Iwate Medical University Hospital or participating institutions between April 1, 2013 and December 31, 2024, were diagnosed with heart failure with reduced ejection fraction, and received treatment. Heart failure with reduced ejection fraction is defined as LVEF <40% according to the Japanese Circulation Society guideline for heart failure.
Key exclusion criteria
1) Patients who underwent invasive treatment for ischemic heart disease. 2) Patients with severe primary valvular heart disease. 3) Patients receiving maintenance dialysis. 4) Patients after implantation of a permanent pacemaker. 5) Patients who declined participation through the opt-out process.
Target sample size
2500
Research contact person
Name of lead principal investigator
| 1st name | Takahito |
| Middle name | |
| Last name | Nasu |
Organization
Division of Cardiology, Department of Internal Medicine, Iwate Medical University
Division name
Division of Cardiology
Zip code
028-3695
Address
2-1-1 Idaidori, Yahaba-cho, Shiwa-gun, Iwate 028-3695, Japan
TEL
019-613-7111
tnasu@iwate-med.ac.jp
Public contact
Name of contact person
| 1st name | Takahito |
| Middle name | |
| Last name | Nasu |
Organization
Iwate Medical University
Division name
Division of Cardiology,
Zip code
028-3695
Address
2-1-1 Idaidori, Yahaba-cho, Shiwa-gun, Iwate 028-3695, Japan
TEL
019-613-7111
Homepage URL
tnasu@iwate-med.ac.jp
Sponsor or person
Institute
Iwate Medical University
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
Iwate Medical University
Address
2-1-1 Idaidori, Yahaba-cho, Shiwa-gun, Iwate 028-3695, Japan
Tel
019-613-7111
tnasu@iwate-med.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
| 2026 | Year | 07 | 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
2500
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
| 2026 | Year | 06 | Month | 11 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 18 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 18 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a multicenter retrospective cohort study including patients who visited the Department of Cardiology at Iwate Medical University Hospital or participating institutions between April 1, 2013 and December 31, 2024, were diagnosed with heart failure with reduced ejection fraction, defined as LVEF <40%, and received treatment. Clinical information, 12-lead electrocardiograms, echocardiographic findings, and laboratory data will be collected from existing medical records at the time of the first visit or diagnosis of HFrEF, at the time of LVEF improvement, and at the time of heart failure worsening events or the last follow-up.
The main exposure is normalization or persistence of abnormalities on 12-lead electrocardiography at the time of LVEF improvement. The primary outcome is heart failure worsening events after reverse remodeling. Secondary outcomes include death after reverse remodeling, the composite endpoint of heart failure worsening events or death, and electrocardiographic findings before reverse remodeling.
Patients will not be randomly sampled. Consecutive eligible patients who meet the inclusion criteria and do not meet any exclusion criteria during the study period will be retrospectively identified. Patients will be given the opportunity to decline participation through an opt-out process.
Management information
Registered date
| 2026 | Year | 06 | Month | 30 | Day |
Last modified on
| 2026 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000071060
