Clinical trial NCT04956952: Enhanced External Counterpulsation in Patients With Fontan Circulation
Official title: Enhanced External Counterpulsation in Patients With Fontan Circulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Single-ventricle
Congenital Heart Disease
Keywords: Fontan
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2021-07-09
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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

Primary outcomes:
measure: Change in cardiac output
timeFrame: Immediately prior to starting EECP treatment, during each 20-minute phase of EECP treatment, and 30 minutes after EECP treatment
measure: Total number and type of adverse events during EECP treatment
timeFrame: During EECP treatment (duration 60 minutes)
measure: Total number and type of adverse events immediately following EECP treatment
timeFrame: From completion of EECP treatment until patient discharge (30 to 60 minutes)
Secondary outcomes:
measure: Change in ventricular strain analysis
timeFrame: Immediately prior to starting EECP treatment, during each 20-minute phase of EECP treatment, and 30 minutes after EECP treatment
measure: Change in qualitative ventricular systolic function
timeFrame: Immediately prior to starting EECP treatment, during each 20-minute phase of EECP treatment, and 30 minutes after EECP treatment
measure: plasma endothelin (ET-1)
timeFrame: pre and 30 minutes post EECP treatment
measure: Total nitrate/nitrite (NOx) levels
timeFrame: pre and 30 minutes post EECP treatment
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Attending Cardiologist
name: Fred Wu, MD
role: PRINCIPAL_INVESTIGATOR
References: