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
Overview
- Phase
- Not Applicable
- Intervention
- Captopril Tablets
- Conditions
- Congenital Mitral Insufficiency
- Sponsor
- China National Center for Cardiovascular Diseases
- Enrollment
- 122
- Locations
- 1
- Primary Endpoint
- the recurrence rate of moderate to severe mitral valve regurgitation
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief 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.
Investigators
Shoujun Li
Director of Congenital Heart Surgery Center
China National Center for Cardiovascular Diseases
Eligibility 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
Arms & Interventions
Modified Drug Therapy Group
Patient in this group will undergo a one-year course of medication, including Captopril(tablet, 0.3mg/kg, tid), Metoprolol(tablet, 0.2mg/kg, bid), Spironolactone(tablet, 2-4mg/kg, bid), Torsemide(tablet, 0.2-0.5mg/mg, bid), and Potassium Citrate(powder, 0.06g/kg, tid).
Intervention: Captopril Tablets
Modified Drug Therapy Group
Patient in this group will undergo a one-year course of medication, including Captopril(tablet, 0.3mg/kg, tid), Metoprolol(tablet, 0.2mg/kg, bid), Spironolactone(tablet, 2-4mg/kg, bid), Torsemide(tablet, 0.2-0.5mg/mg, bid), and Potassium Citrate(powder, 0.06g/kg, tid).
Intervention: Metoprolol Oral Tablet
Modified Drug Therapy Group
Patient in this group will undergo a one-year course of medication, including Captopril(tablet, 0.3mg/kg, tid), Metoprolol(tablet, 0.2mg/kg, bid), Spironolactone(tablet, 2-4mg/kg, bid), Torsemide(tablet, 0.2-0.5mg/mg, bid), and Potassium Citrate(powder, 0.06g/kg, tid).
Intervention: Spironolactone Tablets
Modified Drug Therapy Group
Patient in this group will undergo a one-year course of medication, including Captopril(tablet, 0.3mg/kg, tid), Metoprolol(tablet, 0.2mg/kg, bid), Spironolactone(tablet, 2-4mg/kg, bid), Torsemide(tablet, 0.2-0.5mg/mg, bid), and Potassium Citrate(powder, 0.06g/kg, tid).
Intervention: Torsemide Tablets
Modified Drug Therapy Group
Patient in this group will undergo a one-year course of medication, including Captopril(tablet, 0.3mg/kg, tid), Metoprolol(tablet, 0.2mg/kg, bid), Spironolactone(tablet, 2-4mg/kg, bid), Torsemide(tablet, 0.2-0.5mg/mg, bid), and Potassium Citrate(powder, 0.06g/kg, tid).
Intervention: Potassium citrate powder
the Traditional Drug Therapy Group
Patient in this group will undergo a one-year course of medication, including Torsemide(tablet, 0.2-0.5mg/mg, bid) and Potassium Citrate(powder, 0.06g/kg, tid).
Intervention: Torsemide Tablets
the Traditional Drug Therapy Group
Patient in this group will undergo a one-year course of medication, including Torsemide(tablet, 0.2-0.5mg/mg, bid) and Potassium Citrate(powder, 0.06g/kg, tid).
Intervention: Potassium citrate powder
Outcomes
Primary Outcomes
the recurrence rate of moderate to severe mitral valve regurgitation
Time Frame: after 12 months of treatment
During follow-up visits, echocardiographic examination is conducted to measure the degree of mitral valve regurgitation. If it falls within the moderate to severe range, it is recorded as a recurrence.
Secondary Outcomes
- Change in left ventricular end-diastolic diameter(after 12 months of treatment)
- NT-proBNP level(after 12 months of treatment)
- Improvement in symptoms(after 12 months of treatment)
- Change in left ventricular ejection fraction(after 12 months of treatment)
- Incidence rate of drug adverse reactions(after 12 months of treatment)