UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062477 |
|---|---|
| Receipt number | R000070533 |
| Scientific Title | Implementation of Multidrug therapy for Preserved And mid-range EF in Acute Care |
| Date of disclosure of the study information | 2026/08/05 |
| Last modified on | 2026/08/05 14:03:31 |
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Basic information
Public title
Implementation of Multidrug therapy for Preserved And mid-range EF in Acute Care
Acronym
SAKURA-HF IMPACT
Scientific Title
Implementation of Multidrug therapy for Preserved And mid-range EF in Acute Care
Scientific Title:Acronym
SAKURA-HF IMPACT
Region
| Japan |
Condition
Condition
acute decompensated heart failure, worsening heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the implementation status (adoption rate of GDMT, especially SGLT2 inhibitor and finerenone) during hospitalization and at the time of discharge, as well as the clinical outcomes, safety, and continuity over the following one year.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
GDMT (SGLT2 inhibitor or MRA) adoption rate at the time of discharge.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Age 18 years or older.
2. Heart failure patients hospitalized for acute worsening heart failure (worsening HF) (meeting any of the following simplified criteria).
3. Left ventricular ejection fraction (LVEF) >= 40%.
Key exclusion criteria
1. Patients whose attending physician determines that so-called severe valvular disease was the primary cause of hospitalization (severe AS/AR/MR/MS, etc.).
2. Patients whose attending physician determines that so-called pneumoniae was the primary cause of hospitalization.
3. eGFR <25 ml/min/1.73m2 (eGFR <25 at the start of administration is a contraindication in the Japanese PI).
4. Patients on chronic dialysis.
5. Serum/plasma potassium >5.0 mmol/L at screening (confirmed by repeat measurement if clinically indicated).
6. Pregnant or lactating female.
7. Patients whose investigator determines that these patients are inappropriate for study participation.
8. Cases in which the patient declined to participate in this study.
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | Yasuo |
| Middle name | |
| Last name | Okumura |
Organization
Nihon University Itabashi Hospital
Division name
Division of Cardiology
Zip code
173-8610
Address
30-1 Oyaguchi-kamicho, Itabashi-ku, Tokyo, Japan
TEL
03-3972-8111
okumura.yasuo@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Kitano |
Organization
Nihon University Itabashi Hospital
Division name
Division of Cardiology
Zip code
173-8610
Address
30-1 Oyaguchi-kamicho, Itabashi-ku, Tokyo, Japan
TEL
03-3972-8111
Homepage URL
kitano.daisuke@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University
Institute
Department
Personal name
Yasuo Okumura
Funding Source
Organization
Bayer Yakuhi, Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihon University Itabashi Hospital, Clinical Research Center
Address
30-1 Oyaguchi-kamicho, Itabashi-ku, Tokyo, Japan
Tel
03-3972-8111
med.rinsyokenkyu@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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 05 | 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
| 2026 | Year | 04 | Month | 18 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 13 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2028 | 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 an investigator-initiated, multicenter prospective observational registry. All treatment decisions are made at the discretion of the treating physicians in accordance with routine clinical practice. Bayer Yakuhin, Ltd. provides financial support for the study but has no role in the study design, patient enrollment, data collection, data management, statistical analysis, interpretation of the results, or publication of the study findings.
Management information
Registered date
| 2026 | Year | 08 | Month | 05 | Day |
Last modified on
| 2026 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070533
