Study of Innovative Drug Treatment Therapy for Pediatric Mitral Regurgitation
Study Details
Study Description
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:
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Can a modified drug therapy improve both left ventricular and mitral valve function in pediatric patients with mild to moderate mitral valve regurgitation?
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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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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). |
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
|
| 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). |
Drug: Torsemide Tablets
0.2-0.5mg/mg, bid
Drug: Potassium citrate powder
0.06g/kg, tid
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
- 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.
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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< 14 years old
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had not undertake mitral valve surgery before
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moderate to severe mitral regurgitation
Exclusion Criteria:
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moderate to severe mitral regurgitation which concommitant with other cardiac malformation which can not be correct or can only perform palliative surgery
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concommitant with mitral stenosis
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ischemic mitral regurgitation (for example, concommitant with anomalous origin of coronary artery)
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Barlow syndrome
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dysplasia of mitral leaflet
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complete/Partial endocardial cushion defect
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common atrioventricular valve
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atrioventricular common channel
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cardiomyopathy
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other mitral valve surgery contraindications
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moderate to severe mitral regurgitation requires mitral valve surgery
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fuwai hospital | Beijing | Beijing | China | 100037 |
Sponsors and Collaborators
- China National Center for Cardiovascular Diseases
- Shanghai Children's Medical Center
- Chinese Academy of Medical Sciences, Fuwai Hospital
- Guangzhou Women and Children's Medical Center
- Children's Hospital of Chongqing Medical University
- Fuwai Central China Cardiovascular Hospital, Zhengzhou, China
Investigators
- Study Chair: Shoujun Li, MD, Fuwai Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2022-GSP-GG-19-1