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A multicenter, randomized controlled clinical trial of HeartMed digital therapy for improving the clinical prognosis of patients after coronary artery bypass grafting surgery

A multicenter, randomized controlled clinical trial of HeartMed digital therapy for improving the clinical prognosis of patients after coronary artery bypass grafting surgery - Digital therapeutics improve the prognosis of patients after coronary artery bypass grafting.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600124563
Enrollment
Unknown
Registered
2026-05-13
Start date
2025-11-12
Completion date
Unknown
Last updated
2026-05-18

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

Conditions

Coronary Artery Bypass Grafting (CABG)

Interventions

Intervention group:Innovatively designed, the HeartMed Digital Clinical Management System enables home-based monitoring of indicators such as body weight, heart rate, blood pressure, electrocardiogram
Control group:Regular outpatient follow-up

Sponsors

Beijing Anzhen Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age: 18 to 75 years old (inclusive), gender unrestricted; 2. Patients diagnosed with coronary heart disease (CHD) by imaging examinations who have undergone Coronary Artery Bypass Grafting (CABG); 3. Patients agree to comply with the study protocol and sign the informed consent form (ICF).

Exclusion criteria

Exclusion criteria: 1. Patients who have undergone emergency or rescue surgery; 2. Patients who undergo valvular surgery, major vascular surgery, or other concurrent surgeries; 3. Pregnant or lactating patients, or those planning to become pregnant within 1 year; 4. Patients who have undergone mechanical circulatory support (MCS) (such as intra-aortic balloon pump (IABP), Impella, extracorporeal membrane oxygenation (ECMO), or other MCS modalities) or endotracheal intubation; 5. Patients with a history of viral myocarditis or non-ischemic cardiomyopathies such as dilated cardiomyopathy (DCM), hypertrophic cardiomyopathy (HCM), peripartum cardiomyopathy (PPCM); 6. Patients with moderate to severe valvular heart disease (VHD) or a history of valve replacement; 7. Patients with severe liver dysfunction (alanine aminotransferase [ALT] >= 3 times the upper limit of normal [ULN]) or renal dysfunction (estimated glomerular filtration rate [eGFR] < 60 mL/min/1.73 m^2); 8. Patients with malignancies or other diseases who have a life expectancy of less than 1 year; 9. Patients who are unable to use smartphones for any reason or have difficulty communicating with the study management team; 10. Patients who are currently participating in other clinical trials; 11. Patients who, in the investigator’s judgment, have any other clinical conditions that are not suitable for enrollment in this study.

Design outcomes

Primary

MeasureTime frame
Incidence of composite endpoint (including all-cause mortality, acute myocardial injury, sternotomy, stroke, arrhythmia, bleeding, infection, or acute kidney injury) at 2 years;

Secondary

MeasureTime frame
Quality of life score (SF-36 questionnaire);Self-rating Anxiety Scale score;Self-rating Depression Scale score;Seattle Angina Questionnaire score;

Countries

China

Contacts

Public ContactSong Yue

Beijing Anzhen Hospital, Capital Medical University

fossil2008heart@aliyun.com+86 139 1095 5857

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 22, 2026