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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- the recurrence rate of moderate to severe mitral valve regurgitation
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •< 14 years old
- •had not undertake mitral valve surgery before
- •moderate to severe mitral regurgitation
排除标准
- •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
研究组 & 干预措施
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).
干预措施: Captopril Tablets (Drug)
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).
干预措施: Metoprolol Oral Tablet (Drug)
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).
干预措施: Spironolactone Tablets (Drug)
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).
干预措施: Torsemide Tablets (Drug)
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).
干预措施: Potassium citrate powder (Drug)
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).
干预措施: Torsemide Tablets (Drug)
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).
干预措施: Potassium citrate powder (Drug)
结局指标
主要结局
the recurrence rate of moderate to severe mitral valve regurgitation
时间窗: 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.
次要结局
- 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)
研究者
Shoujun Li
Director of Congenital Heart Surgery Center
China National Center for Cardiovascular Diseases