NCT06037434

Study of Innovative Drug Treatment Therapy 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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 122 (estimated)
• Sponsor: China National Center for Cardiovascular Diseases · Other Government
• Sex: All
• Age: 14 Years
• Healthy volunteers: Not accepted

Summary

The goal of this observational study is to compare the safety and effectiveness of a modified drug therapy with traditional drug therapy in pediatric patients with mild to moderate mitral valve regurgitation. The main questions it aims to answer are: * Can a modified drug therapy improve both left ventricular and mitral valve function in pediatric patients with mild to moderate mitral valve regurgitation? * Can the adverse drug reactions caused by the modified drug therapy be non-inferior (clinically acceptable) to those of the traditional drug therapy? Participants will be assigned to either the Modified Drug Therapy Group (comprising angiotensin-converting enzyme inhibitor (ACE-I), beta-blockers, diuretics, potassium supplements, and spironolactone) or the Traditional Drug Therapy Group (diuretics and potassium supplements) based on personal preferences and clinical assessments by their attending physicians. They will undergo a one-year course of medication. Additionally, echocardiography, electrocardiograms, complete blood counts, biochemical tests, and measurements of N-terminal pro-brain natriuretic peptide (NT-proBNP) were conducted before the initiation of medication therapy and at 3 months, 6 months, and 12 months after treatment commencement. Researchers will compare the Modified Drug Therapy Group and the Traditional Drug Therapy Group to see if the recurrence rate of moderate to severe mitral valve regurgitation, as assessed by echocardiography after 12 months of treatment, is lower in the former than in the latter.

Conditions

• Congenital Mitral Insufficiency

Interventions

Type	Name	Description
DRUG	Captopril Tablets	0.3mg/kg, tid
DRUG	Metoprolol Oral Tablet	0.2mg/kg, bid
DRUG	Spironolactone Tablets	2-4mg/kg, bid
DRUG	Torsemide Tablets	0.2-0.5mg/mg, bid
DRUG	Potassium citrate powder	0.06g/kg, tid

Timeline

• Start date: 2022-04-01
• Primary completion: 2024-08-09
• Completion: 2024-12-31
• First posted: 2023-09-14
• Last updated: 2023-09-15

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study