Study of Pulmonary Artery Banding for the Improvement of Left Ventricular Function in Pediatric Heart Failure
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
1 other identifier
observational
25
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2022
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2022
CompletedFirst Submitted
Initial submission to the registry
September 9, 2023
CompletedFirst Posted
Study publicly available on registry
September 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedSeptember 15, 2023
September 1, 2023
2.7 years
September 9, 2023
September 9, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
NT-proBNP level
after 6 months of PAB surgery
Incidence rate of drug adverse reactions
after 6 months of PAB surgery
Readmission rate for heart failure
after 6 months of PAB surgery
Study Arms (1)
Pulmonary Artery Banding Group
Patient in this group will undergo pulmonary artery banding surgery for congenital heart disease.
Interventions
Patient in this group will undergo pulmonary artery banding surgery for congenital heart disease.
Eligibility Criteria
paitent younger than 14 years of age with heart failure
You may qualify if:
- patients younger than 14 years of age
- congenital heart failure (LVEF\<55%, or LVFS\<25%)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- China National Center for Cardiovascular Diseaseslead
- Peking University First Hospitalcollaborator
- Beijing Children's Hospitalcollaborator
Study Sites (1)
Fuwai hospital
Beijing, Beijing Municipality, 100037, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Shoujun Li, MD
Chinese Academy of Medical Sciences, Fuwai Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 6 Months
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Congenital Heart Surgery Center
Study Record Dates
First Submitted
September 9, 2023
First Posted
September 15, 2023
Study Start
January 1, 2022
Primary Completion
September 1, 2024
Study Completion
December 31, 2024
Last Updated
September 15, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share