congenital heart disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients must meet ALL of the following: (1) Diagnosis of simple or complex congenital heart disease; (2) Undergoing definitive surgical correction under cardiopulmonary bypass (CPB) as an elective procedure at this center; (3) Aged >=6 years and <18 years at the time of surgery; 2.Provision of written informed consent by legal guardian(s) with willingness to voluntarily participate in the study and comply with follow-up requirements
Exclusion criteria
Exclusion criteria: 1. Age at surgery =18 years; 2. Presence of symptomatic or medically/surgically managed non-structural cardiac diseases (including arrhythmias, cardiomyopathies) or acquired heart diseases (including infective endocarditis, acquired valvular diseases, myocarditis); 3. Concurrent symptomatic or medically/surgically managed non-cardiac systemic diseases; 4. History of cardiac surgery or intensive care unit (ICU) admission within the past year; 5. Anticipated requirement for repeat cardiac surgery under cardiopulmonary bypass (CPB) within 12 months postoperatively, as determined by investigators; 6. Medical contraindications to surgery or CPB, as assessed by investigators; 7. Preoperative hospitalization <24 hours, postoperative hospitalization <5 days, or insufficient time for complete perioperative rehabilitation protocol implementation according to investigator judgment; 8. Current participation in other interventional trials or planned enrollment during study period; 9. Inability to complete baseline cardiopulmonary exercise testing (CPET) or Health-Related Quality of Life (HRQoL) assessments; 10. Special circumstances (including pregnancy, substance abuse).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CPET indexes; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety indicators (including death, readmission, reoperation, cardiovascular events, and non-cardiovascular events);The compliance of the subjects in following the CR regimen;Length of stay (total hospital stay, postoperative hospital stay, ICU stay);Severity score of disease;physical development state;Health and physical fitness;Nutritional and immune status;Cardiac function;Heart rate and heart rhythm conditions;Condition of the lungs;Respiratory function;Subject's health-related quality of life;Subject's disease knowledge;Caregiver's emotional and quality of life; | — |
Countries
China
Contacts
Fuwai Hospital, CAMS & PUMC