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

Recruiting

• Conditions: Heart Failure Congenital
• Interventions: Procedure: pulmonary artery banding

• Registration Number: NCT06039553
• Lead Sponsor: China National Center for Cardiovascular Diseases

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-01
• Status Verified: 2023-09
• Study First Submitted: 2023-09-09
• Study First Submitted QC: 2023-09-09
• Last Update Submitted: 2023-09-09
• Study First Posted: 2023-09-15
• Last Update Posted: 2023-09-15
• Primary Completion: 2024-09-01
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pulmonary Artery Banding Group	pulmonary artery banding	Patient in this group will undergo pulmonary artery banding surgery for congenital heart disease.

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Fuwai hospital; 🇨🇳 Beijing, Beijing, China