Study of Innovative Drug Treatment Therapy for Pediatric Mitral Regurgitation
- Conditions
- Congenital Mitral Insufficiency
- Interventions
- Registration Number
- NCT06037434
- Lead Sponsor
- China National Center for Cardiovascular Diseases
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 122
- < 14 years old
- had not undertake mitral valve surgery before
- moderate to severe mitral regurgitation
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description the Traditional Drug Therapy Group Potassium citrate powder 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). Modified Drug Therapy Group Captopril Tablets 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). Modified Drug Therapy Group Spironolactone Tablets 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). Modified Drug Therapy Group Torsemide Tablets 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). Modified Drug Therapy Group Potassium citrate powder 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). Modified Drug Therapy Group Metoprolol Oral Tablet 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). the Traditional Drug Therapy Group Torsemide Tablets 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).
- Primary Outcome Measures
Name Time Method the recurrence rate of moderate to severe mitral valve regurgitation 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 Outcome Measures
Name Time Method Change in left ventricular end-diastolic diameter after 12 months of treatment Based on the echocardiogram, measurements are taken for left ventricular end-diastolic diameter.
NT-proBNP level after 12 months of treatment The trend in NT-proBNP levels.
Improvement in symptoms after 12 months of treatment Based on patient and caregiver descriptions, if symptoms such as chest discomfort, shortness of breath, and delayed development show improvement following physical activity, it is recorded as an improvement in symptoms.
Change in left ventricular ejection fraction after 12 months of treatment Based on the echocardiogram, measurements are taken for left ventricular ejection fraction.
Incidence rate of drug adverse reactions after 12 months of treatment The incidence of abnormalities in complete blood count, electrolytes, liver and kidney function, and cardiac enzymes.
Trial Locations
- Locations (1)
Fuwai hospital
🇨🇳Beijing, Beijing, China