Comparing drug therapies to improve heart function after mitral valve repair in children
A Prospective Controlled Study for the Treatment Effect of Different Intervention Strategies for Pediatric Mitral Regurgitation--A Multicenter Prospective Cohort Study of Innovative Drug Therapy in Improving Left Ventricular Function After Mitral Repair
This study is testing if a new combination of heart medications can help children feel better and improve heart function after they have surgery to fix their mitral valve.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 164 (estimated) |
| Ages | N/A to 14 Years |
| Sex | All |
| Sponsor | China National Center for Cardiovascular Diseases Government |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT06039592 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 pediatric patients who have undergone mitral valve repair. Participants will be assigned to either the Modified Drug Therapy Group, which includes a combination of ACE inhibitors, beta-blockers, diuretics, potassium supplements, and spironolactone, or the Traditional Drug Therapy Group, which consists of diuretics and potassium supplements. The study will monitor improvements in left ventricular and mitral valve function over a 6-month period, alongside assessing any adverse drug reactions. Echocardiography and other clinical assessments will be conducted to gather comprehensive data on patient outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are pediatric patients under 14 years old who have recently undergone mitral valve repair.
Not a fit: Patients with severe heart failure, pulmonary hypertension, or significant organ failure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved heart function and better overall health outcomes for pediatric patients after mitral valve repair.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving outcomes for patients with congenital heart disease.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * under 14 years old * after mitral valve repair Exclusion Criteria: * 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
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.