Summary
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.
Conditions
Single-ventricle, Congenital Heart Disease
Recruitment Status
Completed
Detailed Description
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.
Eligibility Criteria
Inclusion Criteria:
Individuals with Fontan physiology being seen in the Boston Children's Hospital cardiology clinic for outpatient care.
Exclusion Criteria:
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
Intervention
Intervention Type
Intervention Name
Device
EECP
Phase
Not Applicable
Gender
All
Min Age
18 Years
Max Age
N/A
Download Date
June 13, 2023
Principal Investigator
This field has been modified from ClinicalTrials.gov to show a contact specific to Boston Children's.
Primary Contact Information
erica.denhoff@childrens.harvard.edu
617-355-7893
This field has been modified from ClinicalTrials.gov to show a contact specific to Boston Children's.
For more information on this trial, visit clinicaltrials.gov.
Contact
For more information and to contact the study team: