Heart Failure Congenital
Conditions
Keywords
congenital heart disease, pulmonary artery banding
Brief summary
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.
Interventions
PROCEDUREpulmonary artery banding
Patient in this group will undergo pulmonary artery banding surgery for congenital heart disease.
Sponsors
Peking University First Hospital
Beijing Children's Hospital
China National Center for Cardiovascular Diseases
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 14 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the recurrence rate of heart failure | after 6 months of PAB surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NT-proBNP level | after 6 months of PAB surgery | The trend in NT-proBNP levels. |
| Incidence rate of drug adverse reactions | after 6 months of PAB surgery | The incidence of abnormalities in complete blood count, electrolytes, liver and kidney function, and cardiac enzymes. |
| Readmission rate for heart failure | after 6 months of PAB surgery | During follow-up visits, readmission for heart failure will be recorded. |
Countries
China
Contacts
Primary ContactKai Ma, PhD
Backup ContactZheng Dou, PhD
Outcome results
None listed