The goal of this observational study is to compare the safety and effectiveness of a modified drug therapy with traditional drug therapy in pediatric patients after mitral repair. The main questions it aims to answer are: * Can a modified drug therapy improve both left ventricular and mitral valve function in pediatric patients after mitral repair? * Can the adverse drug reactions caused by the modified drug therapy be non-inferior (clinically acceptable) to those of the traditional drug therapy? Participants will be assigned to either the Modified Drug Therapy Group (comprising angiotensin-converting enzyme inhibitor (ACE-I), beta-blockers, diuretics, potassium supplements, and spironolactone) or the Traditional Drug Therapy Group (diuretics and potassium supplements) based on personal preferences and clinical assessments by their attending physicians. They will undergo a 6-months course of medication. Additionally, echocardiography, electrocardiograms, complete blood counts, biochemical tests, and measurements of N-terminal pro-brain natriuretic peptide (NT-proBNP) were conducted before the initiation of medication therapy and at 1 month, 3 months, and 6 months after treatment commencement. Researchers will compare the Modified Drug Therapy Group and the Traditional Drug Therapy Group to see if the recurrence rate of moderate to severe mitral valve regurgitation, as assessed by echocardiography after 6 months of treatment, is lower in the former than in the latter.
Study Type
OBSERVATIONAL
Enrollment
164
0.3mg/kg, tid
0.2mg/kg, bid
2-4mg/kg, bid
0.2-0.5mg/mg, bid
0.06g/kg, tid
Fuwai hospital
Beijing, Beijing Municipality, China
RECRUITINGthe recurrence rate of moderate to severe mitral valve regurgitation
During follow-up visits, echocardiographic examination is conducted to measure the degree of mitral valve regurgitation. If it falls within the moderate to severe range, it is recorded as a recurrence.
Time frame: after 12 months of treatment
Improvement in symptoms
Based on patient and caregiver descriptions, if symptoms such as chest discomfort, shortness of breath, and delayed development show improvement following physical activity, it is recorded as an improvement in symptoms.
Time frame: after 12 months of treatment
Improvement in left ventricular function
Based on the echocardiogram, measurements are taken for left ventricular ejection fraction, left ventricular fractional shortening, left ventricular end-diastolic diameter, left ventricular end-diastolic volume, left ventricular end-systolic diameter, and left ventricular end-systolic volume.
Time frame: after 12 months of treatment
NT-proBNP level
The trend in NT-proBNP levels.
Time frame: after 12 months of treatment
Incidence rate of drug adverse reactions
The incidence of abnormalities in complete blood count, electrolytes, liver and kidney function, and cardiac enzymes.
Time frame: after 12 months of treatment
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