Cyanotic congenital heart disease
Conditions
Interventions
control group:placebo
experimental group:Coenzyme Q10 injection
Sponsors
Shanghai Children’s Medical Center, Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
No minimum to 18 Years
Inclusion criteria
Inclusion criteria: (1) Diagnosis: Confirmed cyanotic congenital heart disease requiring surgical intervention. (2) Age: =5-minute intervals between measurements).
Exclusion criteria
Exclusion criteria: (1) Hepatic dysfunction: ALT >2× upper limit of normal (ULN); (2) Renal dysfunction: Serum creatinine >=2.2 mg/dL (194.5 µmol/L); (3) MRI contraindications: Presence of pacemakers or other MRI-incompatible devices; (4) Metabolic disorders: Diabetes mellitus, hyperthyroidism, or anemia; (5) Neurological conditions: Parkinson’s disease, parkinsonism, tremor, restless legs syndrome, etc.; (6) Respiratory diseases affecting gas exchange: Bronchiectasis, COPD, tuberculosis, idiopathic pulmonary fibrosis, etc.; (7) Other cardiac diseases: Coronary artery disease (confirmed by angiography), history of myocardial infarction, hypertrophic cardiomyopathy, idiopathic dilated cardiomyopathy, severe arrhythmias, etc.; (8) Allergy: Hypersensitivity to injectable CoQ10 or any excipients; (9) Malignancy or systemic diseases: Active cancer or other uncontrolled systemic disorders; (10) Motor system disorders: Conditions restricting physical activity; (11) Aortic cross-clamp time: >120 minutes or requiring secondary clamping; (12) Severe heart failure: LVEF <30%.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Left Ventricular Ejection Fractions; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of cardiac events;NYHA classification;Oxygen saturation;NT-proBNP;Myocardial Enzyme Profile;cytokines; | — |
Countries
China
Contacts
Public ContactHao Zhang
Shanghai Children's Medical Center, Shanghai Jiaotong University School of Medicine
Outcome results
None listed