UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057611 |
|---|---|
| Receipt number | R000065826 |
| Scientific Title | An Exploratory Clinical Trial to Assess the Feasibility of a Heart Failure App Aimed at Overcoming Clinical Inertia and Promoting Optimal Medical Therapy |
| Date of disclosure of the study information | 2025/04/15 |
| Last modified on | 2026/05/18 13:35:52 |
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Basic information
Public title
A Feasibility Study of a New Smartphone Application for Heart Failure
Acronym
A Feasibility Study of a New Smartphone Application for Heart Failure
Scientific Title
An Exploratory Clinical Trial to Assess the Feasibility of a Heart Failure App Aimed at Overcoming Clinical Inertia and Promoting Optimal Medical Therapy
Scientific Title:Acronym
An Exploratory Clinical Trial to Assess the Feasibility of a Heart Failure App Aimed at Overcoming Clinical Inertia and Promoting Optimal Medical Therapy
Region
| Japan |
Condition
Condition
Chronic Heart Failure
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the feasibility of a heart failure app in real-world clinical settings and to explore its effectiveness in supporting optimal medical therapy and addressing clinical inertia.
Basic objectives2
Others
Basic objectives -Others
To evaluate the feasibility of a heart failure app in real-world clinical settings and to explore its effectiveness in supporting optimal medical therapy and addressing clinical inertia.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
App usage rate from Visit 1 to Visit 2, defined as the proportion of days on which patients entered self-measured vital signs into the app at home.
Key secondary outcomes
Change in PAM-13 scores from Visit 1 to Visit 2.
Proportion of patients with an increased dosage of heart failure medications (RAS inhibitors, beta-blockers, or MRAs) between Visit 1 and Visit 2.
Proportion of patients with an increased dosage of RAS inhibitors between Visit 1 and Visit 2.
Proportion of patients with an increased dosage of beta-blockers between Visit 1 and Visit 2.
Proportion of patients with an increased dosage of MRAs between Visit 1 and Visit 2.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
Use of a heart failure app
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Aged 18 years or older and younger than 80 years at the time of consent.
Diagnosed with a left ventricular ejection fraction (LVEF) of 40% or less on recent imaging (within one year prior to enrollment), such as echocardiography or cardiac MRI.
Are regularly attending the cardiology outpatient clinic at the study site, receiving heart failure medications prescribed at the site, and visiting approximately every 28 to 56 days.
Owns a blood pressure monitor and a weight scale.
No history of hospitalization for heart failure in the 90 days prior to the date of informed consent.
Not yet been titrated to the maximum recommended maintenance dose of at least one of the following heart failure medications, as specified in the Japanese Circulation Society guidelines ("2017 JCS/JHFS Guidelines for the Diagnosis and Treatment of Acute and Chronic Heart Failure (Revised Edition)" and "2021 JCS/JHFS Focused Update").
Received a thorough explanation of the study, fully understood its contents, and provided written informed consent.
Key exclusion criteria
Unable to adequately use a smartphone.
Do not have a blood pressure monitor or weight scale at home.
Cannot read Japanese.
Expected to have a prognosis of less than one year.
Receiving continuous intravenous inotropic therapy.
Have a recent (within 3 months prior to enrollment) clinical laboratory value of eGFR less than 15 mL/min/1.73m2.
Using a Left Ventricular Assist Device (LVAD).
Have heart failure classified as NYHA class IV.
Are candidates for heart transplant.
Pregnant, potentially pregnant, or breastfeeding.
Deemed inappropriate for participation in this study by the principal investigator or study coordinators for any other reason.
Target sample size
31
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Seo |
Organization
Department of Cardiology, Nagoya City University
Division name
Department of Cardiology
Zip code
4678601
Address
1, Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya City
TEL
052-853-8221
hayashik@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Kosuke |
| Middle name | |
| Last name | Hayashi |
Organization
Department of Cardiology, Nagoya City University
Division name
Department of Cardiology
Zip code
4678601
Address
1, Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya City
TEL
052-853-8221
Homepage URL
hayashik@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya City University School of Medicine Research Ethics Review Committee
Address
1, Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya City
Tel
052-858-7215
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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 15 | 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
Completed
Date of protocol fixation
| 2025 | Year | 01 | Month | 24 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 13 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 04 | Month | 15 | Day |
Last modified on
| 2026 | Year | 05 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065826
