Study of Pulmonary Artery Banding for the Improvement of Left Ventricular Function in Pediatric Heart Failure

Study Overview
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Brief Summary
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The goal of this observational study is to learn about the safety and effectiveness of pulmonary artery banding(PAB) therapy in pediatric heart failure(PHF) patients. The main questions it aims to answer are: Can PAB therapy improve left ventricular(LV) function in PHF patients especially refractory PHF. Can the complications caused by the PAB therapy be clinically acceptable? Participants underwent PAB therapy will be required to underwent echocardiography, electrocardiograms, complete blood counts, biochemical tests, and measurements of N-terminal pro-brain natriuretic peptide (NT-proBNP) follow-up before the initiation of PAB and at 1 month, 3 months, and 6 months after PAB surgery. Researchers will compare the LV function 6 months after PAB suergey and the preoperative ones to see if there is improvement.

Official Title
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A Comprehensive Research of Pediatric Heart Failure -- A Self-control Study of Pulmonary Artery Banding for the Improvement of Left Ventricular Function in Pediatric Heart Failure

Conditions
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Heart Failure Congenital

Intervention / Treatment
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* Procedure: pulmonary artery banding


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients younger than 14 years of age congenital heart failure (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 |
| --- | --- |
| Pulmonary Artery Banding Group<br>Patient in this group will undergo pulmonary artery banding surgery for congenital heart disease. | Procedure: pulmonary artery banding<br>* Patient in this group will undergo pulmonary artery banding surgery for congenital heart disease.<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 PAB surgery | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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congenital heart disease, pulmonary artery banding