Comparing modified and traditional drug therapies for pediatric heart failure
A Comprehensive Research of Pediatric Heart Failure--A Prospective Cohort Study of Drug Therapy for Pediatric Heart Failure
This study is testing if a new type of medication for children with heart failure after heart surgery works better and is safer than the usual medication.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | N/A to 14 Years |
| Sex | All |
| Sponsor | China National Center for Cardiovascular Diseases Government |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT06039540 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the safety and effectiveness of a modified drug therapy compared to traditional drug therapy in children with heart failure following congenital heart surgery. Participants will be assigned to either the Modified Drug Therapy Group or the Traditional Drug Therapy Group based on their preferences and clinical assessments. The study will monitor improvements in left ventricular function and assess the adverse drug reactions over a 6-month treatment period using various diagnostic tests. The goal is to determine if the modified therapy can provide better outcomes without increasing risks.
Who should consider this trial
Good fit: Ideal candidates for this study are children under 14 years old who have heart failure after congenital heart surgery and meet specific clinical criteria.
Not a fit: Patients with single ventricle anatomy, severe pulmonary hypertension, or those requiring advanced heart failure therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for pediatric heart failure patients, enhancing their heart function and overall health.
How similar studies have performed: While there have been studies on drug therapies for heart failure, this specific comparison of modified versus traditional therapies in pediatric patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients younger than 14 years of age * heart failure after congenital heart surgery * Ross \> 2 or NYHA \> 2 * 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.