Enhanced External Counterpulsation in Patients With Fontan Circulation

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.

Study Overview

• Status: Completed
• Conditions: Congenital Heart Disease; Single-ventricle
• Intervention / Treatment: Device: EECP

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 Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fred Wu, MD; Phone Number: 617-355-7893; Email: fred.wu@cardio.chboston.org
• Study Contact Backup: Name: Erica Denhoff, MPH; Email: erica.denhoff@childrens.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Boston Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Enhanced External Counterpulsation (EECP); 1 hour of treatment with EECP	Device: EECP; 1 hour of treatment with EECP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in cardiac output	Measurement of cardiac output (pulmonary blood flow) in L/min using inert gas rebreathing method (Innocor CO device)	Immediately prior to starting EECP treatment, during each 20-minute phase of EECP treatment, and 30 minutes after EECP treatment
Total number and type of adverse events during EECP treatment	Adverse events will be collected by an investigator and documented using CTCAE criteria	During EECP treatment (duration 60 minutes)
Total number and type of adverse events immediately following EECP treatment	Adverse events will be collected by an investigator and documented using CTCAE criteria	From completion of EECP treatment until patient discharge (30 to 60 minutes)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in ventricular strain analysis	Global mid-ventricle circumferential strain (%) and global longitudinal strain (%) calculated from speckle-tracking echocardiography	Immediately prior to starting EECP treatment, during each 20-minute phase of EECP treatment, and 30 minutes after EECP treatment
Change in qualitative ventricular systolic function	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.	Immediately prior to starting EECP treatment, during each 20-minute phase of EECP treatment, and 30 minutes after EECP treatment
plasma endothelin (ET-1)	This will measure endothelial function	pre and 30 minutes post EECP treatment
Total nitrate/nitrite (NOx) levels	This will measure endothelial function	pre and 30 minutes post EECP treatment

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Investigators: Principal Investigator: Fred Wu, MD, Attending Cardiologist

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2022
• Primary Completion (Actual): May 17, 2023
• Study Completion (Actual): May 17, 2023

Study Registration Dates

• First Submitted: June 1, 2021
• First Submitted That Met QC Criteria: July 7, 2021
• First Posted (Actual): July 9, 2021

Study Record Updates

• Last Update Posted (Actual): June 13, 2023
• Last Update Submitted That Met QC Criteria: June 10, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Fontan
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital; Univentricular Heart
• Other Study ID Numbers: P00037795

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes