HeartMed-HF Digital Therapeutics Improves Exercise Capacity in CHF Patients After AMI
NCT Number: NCT06478732
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Heart Failure
Interventions: OTHER: health services
Sponsor: The First Affiliated Hospital with Nanjing Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 710
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-07-30
Completion Date: 2026-12-31

Summary:
Chronic heart failure (HF) is a severe manifestation and terminal stage of various cardiovascular diseases, with high incidence and mortality rates. Myocardial infarction (MI) is currently one of the most common and significant causes of HF globally. The occurrence of HF after MI significantly increases the mortality risk for patients. Actively controlling risk factors and strengthening outpatient management of HF patients post-MI are crucial for alleviating clinical symptoms and enhancing exercise capacity. Recently, digital health interventions (DHI) have shown promising potential in managing cardiovascular disease patients. However, the application in patients with HF post-MI has not been well-reported. Therefore, this study independently and innovatively designed the HeartMed-HF digital therapeutics to demonstrate its effectiveness and safety in patients with HF after MI.

Primary Outcome Measures: Peak oxygen uptake (peak VO2）, Using cardiopulmonary exercise testing to measure peak VO2, 1 year
Secondary Outcome Measures: 6-minute walking test, Using 6-minute walking test to evaluate exercise tolerance., 1 year|Echocardiographic indexes, Left ventricular end-systolic volume (LVESV), left ventricular diastolic volume (LVEDV), left ventricular ejection fraction (LVEF)., 1 year|Cardiopulmonary exercise testing, Using cardiopulmonary exercise testing (cycle ergometer) to evaluate cardiac tolerance., 1 year|Patient Health Questionnaire-9 (PHQ-9), The PHQ-9 is a commonly used self-administered scale designed to assess the severity and frequency of depressive symptoms. It consists of 9 items covering common depressive symptoms, with each item scored from 0 to 3. The total score ranges from 0 to 27, where higher scores indicate more severe depressive symptoms., 1 year|Generalized anxiety disorder-7 (GAD-7), The GAD-7 is a commonly used self-administered scale designed to assess the severity and frequency of symptoms of generalized anxiety disorder over the past 2 weeks. It consists of 7 items covering common anxiety symptoms, with each item scored from 0 to 3. The total score ranges from 0 to 21, where higher scores indicate more severe anxiety symptoms., 1 year|Clinical events, All-cause mortality, cardiovascular mortality and heart failure rehospitalization, 1 year|36-item short form health survey (SF-36), The SF-36 Health Survey is a commonly used tool for assessing health-related quality of life, aiming to evaluate individuals' physical functioning and health perceptions. SF-36 consists of 36 questions covering 8 dimensions: Physical Functioning (PF), Role Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role Emotional (RE), and Mental Health (MH). Each question offers several options describing different health states, from which respondents choose the one that best fits their condition. Scores are calculated based on weighted allocations and specific algorithms, typically represented as numbers between 0 and 100. Higher scores indicate better health status for the respondent., 1 year|Cost-effectiveness analysis, Patient follow-up 1-year total costs refer to all expenses accrued during a year-long monitoring period, encompassing medical services, medication treatments, laboratory tests, imaging studies, and other directly related healthcare and non-healthcare expenditures. These costs are considered as the cost (C) . The effectiveness (E) is defined as the proportion of patients who did not experience clinical events during the 1-year follow-up. The cost-effectiveness ratio (C/E) is computed based on this measure., 1 year