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Effects of digital health interventions on prognosis in patients with heart failure after myocardial infarction: a multicenter, prospective, randomized controlled study

Effects of digital health interventions on prognosis in patients with heart failure after myocardial infarction: a multicenter, prospective, randomized controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500098360
Enrollment
Unknown
Registered
2025-03-06
Start date
2025-04-01
Completion date
Unknown
Last updated
2025-03-10

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

Conditions

Heart failure after myocardial infarction

Interventions

Experimental group:In addition to receiving regular education, digital health interventions are needed. Namely, the HeartMed-HF digital heart failure therapy independently developed by Chengdu Harite
Control group:Receive routine education, which is carried out during regular patient follow-up.

Sponsors

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. 18 years old to 75 years old. 2. Admission for acute myocardial infarction, including ST elevation myocardial infarction (STEMI) and non-ST elevation myocardial infarction Infarction (NSTEMI). 3. Meet one of the diagnostic criteria for heart failure, including: A. Heart failure with reduced ejection fraction (HFrEF) : symptoms and/or signs of heart failure, LVEF=40%B. Heart failure with mildly reduced ejection fraction (HFmrEF) : symptoms and/or signs of heart failure, 40% =50%, NT-proBNP >=300pg/mL; 4. Barrier-free smartphone users with basic Chinese reading and writing and simple computing skills; 5. Voluntarily participate in the study and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. People with serious diseases and life expectancy of less than 1 year. 2. The patient has a history of dilated cardiomyopathy, perinatal cardiomyopathy, chemotherapy-induced cardiomyopathy, hereditary hypertrophic cardiomyopathy, invasive cardiomyopathy, and viral cardiomytis. 3. The patient has a history of moderate or higher valvular disease. 4. Severe liver dysfunction (ALT or AST exceeding 3 times the upper limit of normal range (ULN), or total bilirubin >1.5mg/dL) and renal dysfunction (eGFR<60mL/min/1.73m^2) due to non-cardiac causes. 5. Malignant tumor patients. 6. A history of drug or alcohol abuse within the last 12 months. 7. Vulnerable groups, including those with mental illness, cognitive impairment, critically ill patients, during pregnancy, breastfeeding or pregnancy Female subjects with positive pregnancytests, etc.

Design outcomes

Primary

MeasureTime frame
All cause death events;Number of re-hospitalizations due to cardiovascular events within 1 year;At 1 year, KCCQ scores increased by 15 points or more from baseline;

Secondary

MeasureTime frame
Cardiovascular death event;1-year risk of unplanned revascularization events;Number of all-cause hospitalizations in 1 year;Left ventricular ejection fraction and NT-proBNP level (1/3/6/12 months);6 minutes walking test;Inpatient and outpatient expenses within 1 year;

Countries

China

Contacts

Public ContactZhang Wenbin

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

3313011@zju.edu.cn+86 137 7757 2567

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026