Study of Innovative Drug Treatment Therapy for Pediatric Mitral Regurgitation

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 patients with mild to moderate mitral valve regurgitation. The main questions it aims to answer are: Can a modified drug therapy improve both left ventricular and mitral valve function in pediatric patients with mild to moderate mitral valve regurgitation? 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 one-year 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 3 months, 6 months, and 12 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 12 months of treatment, is lower in the former than in the latter.

Official Title
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A Prospective Controlled Study for the Treatment Effect of Different Intervention Strategies for Pediatric Mitral Regurgitation--A Multicenter Prospective Cohort Study of Innovative Drug Therapy for Pediatric Mitral Regurgitation

Conditions
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Congenital Mitral Insufficiency

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: < 14 years old had not undertake mitral valve surgery before moderate to severe mitral regurgitation Exclusion Criteria: moderate to severe mitral regurgitation which concommitant with other cardiac malformation which can not be correct or can only perform palliative surgery concommitant with mitral stenosis ischemic mitral regurgitation (for example, concommitant with anomalous origin of coronary artery) Barlow syndrome dysplasia of mitral leaflet complete/Partial endocardial cushion defect common atrioventricular valve atrioventricular common channel cardiomyopathy other mitral valve surgery contraindications moderate to severe mitral regurgitation requires mitral valve surgery

Ages Eligible for Study
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Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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). | 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>|
| the 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 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. | after 12 months of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | after 12 months of treatment | 
| Change in left ventricular ejection fraction | Based on the echocardiogram, measurements are taken for left ventricular ejection fraction. | after 12 months of treatment | 
| Change in left ventricular end-diastolic diameter | Based on the echocardiogram, measurements are taken for left ventricular end-diastolic diameter. | after 12 months of treatment | 
| NT-proBNP level | The trend in NT-proBNP levels. | 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. | after 12 months of treatment | 

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