Enhanced External Counterpulsation in Patients With Fontan Circulation

Congenital Heart Disease Clinical Trial

Official title:

Enhanced External Counterpulsation in Patients With Fontan Circulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04956952
• Other study ID #: P00037795
• Status: Completed
• Phase: N/A
• Start date: March 31, 2022
• Est. completion date: May 17, 2023

Study information

• Verified date: June 2023
• Source: Boston Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: May 17, 2023
• Est. primary completion date: May 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases
• Single-ventricle
• Univentricular Heart

Intervention

Device:
• EECP
1 hour of treatment with EECP

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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)
Primary	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	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
Secondary	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
Secondary	plasma endothelin (ET-1)	This will measure endothelial function	pre and 30 minutes post EECP treatment
Secondary	Total nitrate/nitrite (NOx) levels	This will measure endothelial function	pre and 30 minutes post EECP treatment