Study of Pulmonary Artery Banding for the Improvement of Left Ventricular Function in Pediatric Heart Failure
Study Details
Study Description
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:
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Can PAB therapy improve left ventricular(LV) function in PHF patients especially refractory PHF.
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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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Pulmonary Artery Banding Group Patient in this group will undergo pulmonary artery banding surgery for congenital heart disease. |
Procedure: pulmonary artery banding
Patient in this group will undergo pulmonary artery banding surgery for congenital heart disease.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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patients younger than 14 years of age
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congenital heart failure (LVEF<55%, or LVFS<25%)
Exclusion Criteria:
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single ventricle
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congenital heart disease without anatomical correction
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Patients with heart failure requiring ventricular assist or cardiac synchronization therapy
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Patients with severe pulmonary hypertension (pulmonary arterial pressure >6 Wood·U)
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Patients with severe liver and kidney failure
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Patients who are allergic to related medications
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Patients with symptomatic hypotension who cannot tolerate related drugs
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Refuse to sign the informed consent or refuse to participate in this experiment
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fuwai hospital | Beijing | Beijing | China | 100037 |
Sponsors and Collaborators
- China National Center for Cardiovascular Diseases
- Peking University First Hospital
- Beijing Children's Hospital
Investigators
- Study Chair: Shoujun Li, MD, Fuwai Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2022-1-4032-2