Enhanced External Counterpulsation in Patients With Fontan Circulation

Not Applicable

Completed

• Conditions: Single-ventricle; Congenital Heart Disease
• Interventions: Device: EECP

• Registration Number: NCT04956952
• Lead Sponsor: Boston Children's Hospital

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.

Study Timeline

• Study First Submitted: 2021-06-01
• Study First Submitted QC: 2021-07-07
• Study First Posted: 2021-07-09
• Study Start: 2022-03-31
• Primary Completion: 2023-05-17
• Study Completion: 2023-05-17
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-10
• Last Update Posted: 2023-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Enhanced External Counterpulsation (EECP)	EECP	1 hour of treatment with EECP

Primary Outcome Measures

Name	Time	Method
Total number and type of adverse events immediately following EECP treatment	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	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	During EECP treatment (duration 60 minutes)	Adverse events will be collected by an investigator and documented using CTCAE criteria

Secondary Outcome Measures

Name	Time	Method
plasma endothelin (ET-1)	pre and 30 minutes post EECP treatment	This will measure endothelial function
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	Qualitative assessment of systolic function of dominant ventricle on 2-dimensional echocardiography, categorized as normal, low normal to mildly depressed, mildly depressed, mildly to moderately depressed, moderately depressed, moderately to severely depressed, severely depressed, or unable to determine.
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	Global mid-ventricle circumferential strain (%) and global longitudinal strain (%) calculated from speckle-tracking echocardiography
Total nitrate/nitrite (NOx) levels	pre and 30 minutes post EECP treatment	This will measure endothelial function

Trial Locations

Locations (1)

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States