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临床试验/NCT00208806
NCT00208806已完成不适用

Clinical Evaluation of Dilated Cardiomyopathy and Cardiac Resynchronization Therapy for Ventricular Dysfunction in Young Patients With and Without Congenital Heart Disease

Emory University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2004年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1

研究概览

简要总结

Pacemakers can be attached to one or more than one of the heart chambers. After watching pacemakers work over time, doctors have found that the pacemakers that stimulate only one chamber of the heart sometimes lead to problems later. These problems may be changes in the size and shape of the heart. The heart cannot work as well when some of these changes happen. We need to learn more about these changes and how to prevent them. There has not been an easy way to do this. A new treatment called Cardiac Resynchronization Therapy (CRT) is associated with biventricular pacing where two chambers of the heart are stimulated simultaneously. Tissue Doppler Imaging,Tissue Synchronization Imaging and 3 dimensional echocardiography are new forms of technology that look at the heart while it works. They are similar to a moving x-ray that can watch the heart muscles moving. The movement can be measured. Doctors will check for changes that happen over time. This has not been studied in children before because this kind of is new to this group of patients. This technology is noninvasive which means it can be done from the outside of the body and is painless.

The hearts of children grow fast. It is important to be able to know if the pacemaker or problems from dilated cardiomyopathy are causing any changes in the heart that might cause problems. We expect to be able to use information we learn from this study to improve how we use pacemakers in the future to avoid problems that can happen over time.

详细描述

Hypothesis H1: Children with DCM. Ventricular dyssynchrony is seen in a majority (over 50%) of pediatric patients with DCM.

Specific aim, SA 1: To describe changes in right and left ventricular function using Tissue Synchronization Imaging (TSI),Tissue Doppler Imaging (TDI), 3D echocardiography and conventional echocardiogram parameters in children with dilated cardiomyopathy.

Hypothesis H2: In the pediatric population, clinical signs and symptoms related to dilated cardiomyopathy are improved with the use of biventricular pacing.

Specific aim, SA 2: To quantitate the effects of biventricular pacing therapy on ventricular function in children with dilated cardiomyopathy using Tissue Synchronization Imaging (TSI),Tissue Doppler Imaging (TDI, 3D echocardiography and conventional echocardiographic parameters.

Research Design and Methods

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
1 Day 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed with dilated cardiomyopathy
  • normal heart anatomy or those with repaired congenital defects that have a 4 chambered heart
  • referred for a Biventricular pacemaker implantation or upgrade with the diagnosis of dilated cardiomyopathy or for an echocardiogram due to the diagnosis of dilated cardiomyopathy without pacemaker
  • signed informed consent

排除标准

  • cannot travel back to Children's Healthcare of Atlanta for follow-up
  • Patients with a transplanted heart
  • no informed consent

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Margaret Strieper

Principal Investigator

Emory University

研究点 (1)

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