Trial of ACE Inhibition in Children With Mitral Regurgitation After Repair of AVSD
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 7
- 主要终点
- Comparison of the effect of ACE-I therapy with that of placebo on left ventricular size
研究概览
简要总结
This study will evaluate the efficacy and safety of angiotensin converting enzyme inhibition (ACE-I) therapy for the treatment of mitral regurgitation (MR).
详细描述
BACKGROUND:
MR causes volume overload and hemodynamic burden on the left ventricle. Initial compensatory mechanisms may fail, leading to increased severity. Patients who have had repair of an atrioventricular septal defect (AVSD) are selected for this study as they have a relatively high incidence of moderate MR and their regurgitant orifice is mobile and dynamic, contributing to the likelihood that they might respond to medical therapy.
DESIGN NARRATIVE:
This is a randomized, double-blind, placebo-controlled trial of ACE-I therapy in children less than 18 years of age with at least moderate MR who are at least 6 months postoperative from repair of an AVSD. A non-randomized Observational Phase enrolled 181 children who were less than 6 months postoperative from repair of an AVSD, who were then evaluated at 6 months for trial eligibility.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children less than 18 years of age and at least 6 months post AVSD repair or reoperation
- •At least moderate MR
- •Asymptomatic or minimally symptomatic, defined by Ross Heart Failure Class I or II
- •Atrioventricular synchrony (paced or intrinsic)
排除标准
- •Tetrology of Fallot, total or partial anomalous venous connection
- •More than trivial MS or outflow obstruction
- •Other sources of LV volume overload
- •Hypertrophic obstructive cardiomyopathy
- •Significant residual coarctation
研究组 & 干预措施
1
干预措施: Placebo (Other)
2
Ace inhibition (enalapril)
干预措施: Enalapril (Drug)
结局指标
主要结局
Comparison of the effect of ACE-I therapy with that of placebo on left ventricular size
时间窗: Measured after six months of therapy
次要结局
- Comparison of the effect of ACE-I therapy with placebo on MR severity, left ventricular geometry, hemodynamics, and signs and symptoms of congestive heart failure(6 months on study drug)
- Evaluation of the early natural history of MR in the six months after repair of an AVSD(6 months on study drug)
- Comparison of the incidence of adverse events occurring in subjects treated with ACE-I therapy to that in subjects receiving placebo (measured after six months of therapy)(6 months on safety drug)
研究者
Lois LuAnn Minich
Primary Investigator
University of Utah