Improving heart function in children with heart failure using pulmonary artery banding
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
China National Center for Cardiovascular Diseases · NCT06039553
This study is testing if a procedure called pulmonary artery banding can help improve heart function in children with heart failure.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 25 (estimated) |
| Ages | N/A to 14 Years |
| Sex | All |
| Sponsor | China National Center for Cardiovascular Diseases (other gov) |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT06039553 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the safety and effectiveness of pulmonary artery banding (PAB) therapy in pediatric patients suffering from heart failure. The study will assess whether PAB can enhance left ventricular function, particularly in cases of refractory heart failure. Participants will undergo a series of tests, including echocardiograms and blood tests, before and after the PAB procedure to monitor improvements in heart function over a six-month period. The study will also investigate the acceptability of any complications arising from the PAB therapy.
Who should consider this trial
Good fit: Ideal candidates for this study are children under 14 years old with congenital heart failure and left ventricular ejection fraction below 55%.
Not a fit: Patients with single ventricle anatomy or severe pulmonary hypertension may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve heart function in children with congenital heart failure.
How similar studies have performed: While the approach of using pulmonary artery banding is established, this specific observational study aims to provide new insights into its effectiveness in pediatric heart failure, making it a novel evaluation.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Beijing, Beijing
- Fuwai hospital — Beijing, Beijing, China (RECRUITING)
Study contacts
- Study coordinator: Kai Ma, PhD
- Email: drmakaifw@yahoo.com
- Phone: +86 15901428497
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Heart Failure Congenital, congenital heart disease, pulmonary artery banding