Study of Drug Therapy for Pediatric Heart Failure

Study Overview
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Brief Summary
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The goal of this observational study is to compare the safety and effectiveness of a modified drug therapy with traditional drug therapy in pediatric heart failure patients. The main questions it aims to answer are: Can a modified drug therapy improve left ventricular function in pediatric heart failure patients? 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.

Official Title
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A Comprehensive Research of Pediatric Heart Failure--A Prospective Cohort Study of Drug Therapy for Pediatric Heart Failure

Conditions
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Heart Failure Congenital

Intervention / Treatment
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* Drug: Captopril Tablets
* Drug: Metoprolol Oral Tablet
* Drug: Spironolactone Tablets
* Drug: Torsemide Tablets
* Drug: Potassium citrate powder


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients younger than 14 years of age heart failure after congenital heart surgery Ross > 2 or NYHA > 2 LVEF<55%, or LVFS<25% Exclusion Criteria: single ventricle congenital heart disease without anatomical correction Patients with heart failure requiring ventricular assist or cardiac synchronization therapy Patients with severe pulmonary hypertension (pulmonary arterial pressure >6 Wood·U) Patients with severe liver and kidney failure Patients who are allergic to related medications Patients with symptomatic hypotension who cannot tolerate related drugs Refuse to sign the informed consent or refuse to participate in this experiment

Ages Eligible for Study
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Maximum Age: 14 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Modified Drug Therapy Group<br>Patient in this group will undergo a one-year course of medication, including Captopril(tablet, 0.3mg/kg, tid), Metoprolol(tablet, 0.2mg/kg, bid), Spironolactone(tablet, 2-4mg/kg, bid), Torsemide(tablet, 0.2-0.5mg/ mg, bid), and Potassium Citrate(powder, 0.06g/kg, tid).e Traditional Drug Therapy Group | Drug: Captopril Tablets<br>* 0.3mg/kg, tid<br>Drug: Metoprolol Oral Tablet<br>* 0.2mg/kg, bid<br>Drug: Spironolactone Tablets<br>* 2-4mg/kg, bid<br>Drug: Torsemide Tablets<br>* 0.2-0.5mg/mg, bid<br>Drug: Potassium citrate powder<br>* 0.06g/kg, tid<br>|
| Traditional Drug Therapy Group<br>Patient in this group will undergo a one-year course of medication, including Torsemide(tablet, 0.2-0.5mg/mg, bid) and Potassium Citrate(powder, 0.06g/kg, tid). | Drug: Torsemide Tablets<br>* 0.2-0.5mg/mg, bid<br>Drug: Potassium citrate powder<br>* 0.06g/kg, tid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the recurrence rate of heart failure | During follow-up visits, echocardiographic examination is conducted to measure the left ventricular function. If LVEF falls under 55%, it is recorded as a recurrence. | after 6 months of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NT-proBNP level | The trend in NT-proBNP levels. | after 6 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. | after 6 months of treatment | 
| Readmission rate for heart failure | During follow-up visits, readmission for heart failure will be recorded. | after 6 months of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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congenital heart failure, drug therapy, congenital heart disease postoperative