Congenital Heart Disease Clinical Trial
Official title:
Enhanced External Counterpulsation in Patients With Fontan Circulation
NCT number | NCT04956952 |
Other study ID # | P00037795 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 31, 2022 |
Est. completion date | May 17, 2023 |
Verified date | June 2023 |
Source | Boston Children's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Boston Children's Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Boston Children's Hospital |
United States,
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 |
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