Enhanced External Counterpulsation in Patients With Fontan Circulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Total number and type of adverse events immediately following EECP treatment
研究概览
简要总结
The purpose of the proposed study is to determine the safety of enhanced external counterpulsation (EECP), a system for compressing the blood vessels in the legs in synchrony with an individual's cardiac rhythm, in clinically well, adult Fontan patients, to document the acute hemodynamic and myocardial effects of EECP on the Fontan circulation, and to demonstrate acute changes in endothelial function after one hour of the procedure.
详细描述
The investigators plan to study the effects of enhanced external counterpulsation (EECP), on patients who have had Fontan surgery for treatment of complex congenital heart disease. Eligible patient volunteers will undergo a series of biophysical measurements at rest including echocardiographic assessment of ventricular function, pulmonary blood flow/cardiac output measurement using an inert gas rebreathing method (Innocor), and measurements of biomarkers of endothelial function (ET-1, NOx). Patients will then undergo 1 hour of treatment with EECP, during which additional echocardiographic assessment of ventricular function and pulmonary blood flow/cardiac output measurements will be performed at multiple levels of leg compression. Subjects will be assessed periodically for adverse effects and discomfort during the EECP treatment. At the completion of treatment, patients will be allowed 30 minutes to rest before undergoing one more echocardiographic assessment of ventricular function, pulmonary blood flow/cardiac output measurement, and measurements of biomarkers of endothelial function (ET-1, NOx). Measurements made during and after treatment will be compared to baseline measurements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals with Fontan physiology being seen in the Boston Children's Hospital cardiology clinic for outpatient care.
排除标准
- •Current pregnancy
- •Decompensated heart failure/pulmonary edema
- •Severe aortic insufficiency
- •Active tachyarrhythmias
- •Frequent atrial or ventricular ectopy
- •Symptomatic peripheral vascular disease
- •Thrombophlebitis or history of deep vein thrombosis or stasis ulcer
- •Aortic aneurysm
- •Uncontrolled hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure>110 mmHg)
- •Systolic blood pressure <90 mmHg
- •Active femoral site bleeding or hematoma
结局指标
主要结局
Total number and type of adverse events immediately following EECP treatment
时间窗: From completion of EECP treatment until patient discharge (30 to 60 minutes)
Adverse events will be collected by an investigator and documented using CTCAE criteria
Change in cardiac output
时间窗: Immediately prior to starting EECP treatment, during each 20-minute phase of EECP treatment, and 30 minutes after EECP treatment
Measurement of cardiac output (pulmonary blood flow) in L/min using inert gas rebreathing method (Innocor CO device)
Total number and type of adverse events during EECP treatment
时间窗: During EECP treatment (duration 60 minutes)
Adverse events will be collected by an investigator and documented using CTCAE criteria
次要结局
- plasma endothelin (ET-1)(pre and 30 minutes post EECP treatment)
- Change in qualitative ventricular systolic function(Immediately prior to starting EECP treatment, during each 20-minute phase of EECP treatment, and 30 minutes after EECP treatment)
- Change in ventricular strain analysis(Immediately prior to starting EECP treatment, during each 20-minute phase of EECP treatment, and 30 minutes after EECP treatment)
- Total nitrate/nitrite (NOx) levels(pre and 30 minutes post EECP treatment)
研究者
Fred Wu, MD
Principal Investigator
Boston Children's Hospital