UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054565 |
|---|---|
| Receipt number | R000062346 |
| Scientific Title | The Multicenter STudy On a Precise algorithm for diagnosis of Heart Failure with Preserved Ejection Fraction (STOP-HFPEF) |
| Date of disclosure of the study information | 2024/07/01 |
| Last modified on | 2024/12/04 09:08:38 |
* 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
The Multicenter STudy On a Precise algorithm for diagnosis of Heart Failure with Preserved Ejection Fraction (STOP-HFPEF)
Acronym
STOP-HFPEF
Scientific Title
The Multicenter STudy On a Precise algorithm for diagnosis of Heart Failure with Preserved Ejection Fraction (STOP-HFPEF)
Scientific Title:Acronym
STOP-HFPEF
Region
| Japan |
Condition
Condition
heart failure with preserved ejection fraction
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop HFpEF diagnostic criteria based on data from Asian countries, expanding the scope to include patients classified as heart failure stages A and B according to current guidelines
Basic objectives2
Others
Basic objectives -Others
To develop HFpEF diagnostic approaches that incorporate exercise stress echocardiography
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To establish a novel HFpEF diagnostic algorithm
Key secondary outcomes
To evaluate the clinical utility of this new HFpEF diagnostic score, secondary outcomes will include comparisons of heart failure incidence rates, cardiovascular death, the number of major cardiovascular events (acute coronary syndrome, heart failure requiring hospitalization, incident atrial fibrillation), and overall mortality rates.
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
Participants aged 20 years and older are included if they meet the criteria outlined in the Japanese Circulation Society Acute and Chronic Heart Failure Guidelines, as well as the classification of heart failure stages defined by joint reports from the American, European, and Japanese Heart Failure Societies. Specifically, cases in stage A or B, representing risk stages of heart failure, and those diagnosed with stage C heart failure are targeted.
Key exclusion criteria
Exclusion criteria are as follows: (1) patients unable or unwilling to provide written consent, (2) patients for whom appropriate echocardiographic images for image analysis cannot be obtained, (3) patients with two or more heart failure hospitalizations within the past year (fitting the criteria for stage D heart failure), (4) patients post-mitral valve intervention (post-mitral valve repair, replacement, or clip placement), (5) patients with planned cardiac surgery at the time of enrollment, (6) patients with severe aortic valve or mitral valve disease, (7) patients on dialysis (including scheduled patients), and (8) cases where heart failure symptoms or clinical signs worsen and medication changes are made between patient enrollment in the study and the conduct of exercise stress echocardiography.
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiro |
| Middle name | |
| Last name | SEO |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Cardiology
Zip code
467-8601
Address
1 Kawasumi, Mizuhocho, Nagoya, Japan.
TEL
052-853-8221
yo-seo@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Yu |
| Middle name | |
| Last name | KAWADA |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Cardiology
Zip code
467-8601
Address
1 Kawasumi, Mizuhocho, Nagoya, Japan.
TEL
052-853-8221
Homepage URL
yu.kawada@outlook.jp
Sponsor or person
Institute
Nagoya City University Graduate School of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya City University Institutional Review Board
Address
1, Kawasumi Mizuho-cho, Mizuho-ku, Nagoya
Tel
+81-052-836-3460
clinical_research@med.nagoya-cu.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
国内30施設
Other administrative information
Date of disclosure of the study information
| 2024 | 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
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
| 2023 | Year | 07 | Month | 11 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patient enrollment commenced on the date of study approval and will conclude on December 31, 2025. Patients will be followed for a minimum of one year after enrollment.
Management information
Registered date
| 2024 | Year | 06 | Month | 04 | Day |
Last modified on
| 2024 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062346
