Study of Pulmonary Artery Banding for the Improvement of Left Ventricular Function in Pediatric Heart Failure
NCT ID: NCT06039553
Last Updated: 2023-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
25 participants
OBSERVATIONAL
2022-01-01
2024-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Pulmonary Artery Banding Group
Patient in this group will undergo pulmonary artery banding surgery for congenital heart disease.
pulmonary artery banding
Patient in this group will undergo pulmonary artery banding surgery for congenital heart disease.
Interventions
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pulmonary artery banding
Patient in this group will undergo pulmonary artery banding surgery for congenital heart disease.
Eligibility Criteria
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Inclusion Criteria
* congenital heart failure (LVEF\<55%, or LVFS\<25%)
Exclusion Criteria
* 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
14 Years
ALL
No
Sponsors
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Peking University First Hospital
OTHER
Beijing Children's Hospital
OTHER
China National Center for Cardiovascular Diseases
OTHER_GOV
Responsible Party
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Shoujun Li
Director of Congenital Heart Surgery Center
Principal Investigators
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Shoujun Li, MD
Role: STUDY_CHAIR
Chinese Academy of Medical Sciences, Fuwai Hospital
Locations
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Fuwai hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2022-1-4032-2
Identifier Type: -
Identifier Source: org_study_id
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