Effects of Smartphone Heart Failure APPs and Remote Cardiac Rehabilitation on Prognosis and Exercise Capacity in Acute Coronary Syndrome Patients (SHARE-CR study)

JRCT ID: jRCT1040240079

Registered date:29/08/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Acute coronary syndrome
• Date of first enrollment: 29/08/2024
• Target sample size: 84
• Study type: Interventional
• Intervention(s): In the intervention group, a Fitbit will be linked to the Heart Signs app for heart failure management and remote exercise guidance based on heart rate and exercise intensity during exercise. The control group will use the regular Heart Signs app.

Outcome(s)

• Primary Outcome: Change in peak VO2
• Secondary Outcome: Percent change in peak VO2, anaerobic threshold (AT), 24-hour blood pressure by 24-hour blood pressure monitor (ABPM), daytime blood pressure, nighttime blood pressure, evaluation of blood pressure variability, left ventricular systolic and diastolic function, left ventricular volume, left ventricular ejection fraction, left and right ventricular yesterday by echocardiography, Kansas City as quality of life index Cardiomyopathy Questionnaire (KCCQ)-CSS, KCCQ-TSS, KCCQ-OSS change from baseline, Fitbit information: amount of exercise (steps, exercise duration, distance traveled, METs), heart rate during exercise, heart failure hospitalizations and cardiovascular adverse events during the 6- and 12-month observation periods

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patients are 18 years of age or older
2) Patients with early revascularization for ACS who are scheduled for discharge home
3) Patients with NYHA class I-III HF symptoms and HF Stage B or C
4) Patients with a smartphone that can be connected to the Internet environment and on which the application can be installed.
5) Patients who agree to participate in research

Exclude criteria

1) Patients who do not have access to an Internet environment or do not have a smartphone capable of installing applications
2) Patients who are unable to use a smartphone due to cognitive or physical decline or disability
3) Patients who cannot install the application or agree to the terms of service
4) Patients who had a stroke, transient ischemic attack, or surgery on the cardiovascular, carotid, or other major cardiac vessels within 3 months
5) Patients who are unable to walk or do other physical activities
6) Patients with residual unstable angina pectoris
7) Patients with scheduled cardiac bypass surgery
8) Patients who are expected to be hospitalized for longer than 28 days for ACS
9) Patients who are pregnant, possibly pregnant, or lactating patients
10) Patients whose heart failure symptoms are NYHA IV and require continuous inpatient care
11) Patients with persistent atrial fibrillation
12) Patients who will participate in outpatient cardiac rehabilitation
13) Patients who are deemed inappropriate for inclusion in the study by the principal investigator or co-investigator
14) Patients with heart failure who have already participated in the Heart Signs Study
15) Patients who wish to continue using the conventional paper-based heart failure handbook

Related Information

• Primary Sponsor: Fujimoto Naoki
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development,Mie Junkanki/Jinsikkan Network,Nabari City, Mie,Mie University Hospital