The Effect of Transcatheter Ventricular Septal Defect Closure on Heart Rate Variability Parameters
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Heart rate variability parameters
研究概览
简要总结
In this study; we evaluated the heart rate variability parameters of pediatric patients whose VSDs were closed with the transcatheter method before and after, and compared with the control group.
详细描述
Heart rate variability (HRV) is a sign of cardiac autonomic nervous system. Evaluation of HRV in pediatric ventricular septal defect (VSD) cases before and after transcatheter closure will enlighten us in terms of cardiac autonomic control.
Methods: 19 VSD cases treated with transcatheter closure method and 18 healthy children were enrolled in the study. 24 hours Holter rhythm monitorization was applied to all patients before closure of VSD and to the control group. In the patient group, Holter rhythm monitorization was repeated in the third months. HRV parameters were obtained from Cardio Scan Premier 12® program. Frequency domain (Total power, VLF, LF, HF, LF/HF ratio) and time domain analysis (SDNN, SDANN, SDNNi, pNN50, rMSSD) were applied.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 56 Months 至 136 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •VSD diameter <6mm
- •Significant left-to-right shunt
- •Left atrial and ventricular enlargement detected by echocardiography or calculation of Qp/Qs ratio above 1.5 in the catheterization laboratory (Qp/Qs>1.5)
排除标准
- •Patients with arrhythmia after the procedure
- •Young patients who may be inconsistent during Holter records
结局指标
主要结局
Heart rate variability parameters
时间窗: 24 hours
Time Domain analysis: After ectopic beats and artifacts were excluded, the following indices were calculated for time domian analysis in the whole Holter recording. * SDNN: Standard deviation of all filtered RR intervals * SDANN: Standard deviation of 5-minute averages of RR intervals * SDNNindex: Mean of the standard deviation of all RR intervals for all the 5-minute segments * rMSSD: Square root of the mean of the sum of square differences between adjacent filtered RR interval * PNN50: Percentage of the difference between adjacent RR intervals greater than 50 milliseconds Frequency domain analysis: We determined spectral power over three frequency. * Very low frequency (VLF) index (0.003-0.04 Hz) * Low frequency (LF) index (0.04 - 0.15 Hz) * High frequency (HF) index (0.15 - 0.40 Hz) * Total power: Variance of all NN intervals approximately \<0.4 Hz
次要结局
未报告次要终点
研究者
süleyman sunkak
Principal Investigator
Kayseri City Hospital