Assessment of efficacy of early introduction of ACE (angiotensin converting enzyme) inhibitors in treatment of congestive heart failure in children with medium sized ventricular septal defects: a single center open label randomized trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Resolution of respiratory distress (based on respiratory rate (/min) (resolution of tachypnea), retractions – subcostal/intercostal/suprasternal, nasal flaring and grunting).
研究概览
简要总结
**Aim of the study:**To assess the efficacy of early introduction of ACE (angiotensin converting enzyme) inhibitors in treatment of congestive heart failure in children with medium sized ventricular septal defects.
**Primary Objective:**To assess the efficacy of early introduction of ACE (angiotensin converting enzyme) inhibitors in treatment of congestive heart failure in children with medium sized ventricular septal defects. The efficacy will be assessed based on resolution of respiratory distress (respiratory rate (resolution of tachypnea), retractions – subcostal/intercostal/suprasternal, nasal flaring and grunting) and resolution of signs of heart failure – regression of liver size below right costal margin.
Secondary Objectives:
i. To observe and analyze the spectrum of patients presenting with VSD in AIIMS Patna.
ii. To assess the duration of treatment with diuretics and enalapril after which clinical symptoms of congestive heart failure improve in patients with moderate VSD.
Hypothesis:
**a.**Null hypothesis (H0): There is no difference in resolution of symptoms and signs of congestive heart failure with early introduction of ACE inhibitors in patients with medium sized VSD.
b. Alternate hypothesis (H1): There is better resolution of symptoms and signs of congestive heart failure with early introduction of ACE inhibitors in children with medium sized VSD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 1.00 Month(s) 至 10.00 Year(s)（—）
- 性别
- All
入选标准
- •All children aged 1 month to 10 years of either sex with medium sized VSD (diagnosed by 2D echo) presenting with congestive heart failure.
排除标准
- •Patients already on enalapril ii.
- •Patients who have already undergone surgical correction of VSD iii.
- •Patients with small and large sized VSD iv.
- •Patients with renal dysfunction or hyperkalemia v.
- •Patients with cardiogenic shock.
结局指标
主要结局
Resolution of respiratory distress (based on respiratory rate (/min) (resolution of tachypnea), retractions – subcostal/intercostal/suprasternal, nasal flaring and grunting).
时间窗: 1 week and 1 month after starting intervention
次要结局
- i. Resolution of signs of heart failure – regression of liver size below right costal margin (in cm) and difference in liver span (in cm)(ii. Number of admissions and total days of admission)
研究者
Dr Chandra Raj Datta
All India Institute of Medical Sciences, Patna