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

National Center for Cardiovascular Diseases

Status

Enrolling

Conditions

Heart Failure Congenital

Treatments

Procedure: pulmonary artery banding

Study type

Observational

Funder types

Other

Identifiers

NCT06039553

2022-1-4032-2

Details and patient eligibility

About

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.

Enrollment

25 estimated patients

Sex

All

Ages

Under 14 years old

Volunteers

No Healthy Volunteers

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