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A Feasibility Study of a New Smartphone Application for Heart Failure

An Exploratory Clinical Trial to Assess the Feasibility of a Heart Failure App Aimed at Overcoming Clinical Inertia and Promoting Optimal Medical Therapy - An Exploratory Clinical Trial to Assess the Feasibility of a Heart Failure App Aimed at Overcoming Clinical Inertia and Promoting Optimal Medical Therapy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000057611
Enrollment
31
Registered
2025-04-15
Start date
2025-04-15
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Heart Failure

Interventions

Use of a heart failure app

Sponsors

Nagoya City University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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.

Countries

Japan

Contacts

Public ContactKosuke Hayashi

Department of Cardiology, Nagoya City University Department of Cardiology

hayashik@med.nagoya-cu.ac.jp052-853-8221

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026