Innovative drug treatment for pediatric mitral regurgitation
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 for Pediatric Mitral Regurgitation
This study is testing whether a new combination of heart medications can help children with mild to moderate mitral valve regurgitation feel better compared to standard treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 122 (estimated) |
| Ages | N/A to 14 Years |
| Sex | All |
| Sponsor | China National Center for Cardiovascular Diseases Government |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT06037434 on ClinicalTrials.gov |
What this trial studies
This observational study aims to compare the safety and effectiveness of a modified drug therapy against traditional drug therapy in children with mild to moderate mitral valve regurgitation. 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 assess improvements in left ventricular and mitral valve function over a one-year medication course, while also monitoring adverse drug reactions. The assignment will be based on personal preferences and clinical assessments by attending physicians.
Who should consider this trial
Good fit: Ideal candidates are children under 14 years old with moderate to severe mitral regurgitation who have not undergone mitral valve surgery.
Not a fit: Patients with other significant cardiac malformations or conditions that require surgical intervention may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for pediatric patients with mitral regurgitation, enhancing their heart function and overall health.
How similar studies have performed: While there have been studies on drug therapies for heart conditions, this specific approach in pediatric mitral regurgitation is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * \< 14 years old * had not undertake mitral valve surgery before * moderate to severe mitral regurgitation Exclusion Criteria: * moderate to severe mitral regurgitation which concommitant with other cardiac malformation which can not be correct or can only perform palliative surgery * concommitant with mitral stenosis * ischemic mitral regurgitation (for example, concommitant with anomalous origin of coronary artery) * Barlow syndrome * dysplasia of mitral leaflet * complete/Partial endocardial cushion defect * common atrioventricular valve * atrioventricular common channel * cardiomyopathy * other mitral valve surgery contraindications * moderate to severe mitral regurgitation requires mitral valve surgery
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.