Single-ventricleNCT04956952
Enhanced External Counterpulsation in Patients With Fontan Circulation
A study testing EECP in people with Single-ventricle and Congenital Heart Disease, run by Boston Children's Hospital at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Single-ventricle, Congenital Heart Disease
- What is being tested?
- EECP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2022to 17 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals with Fontan physiology being seen in the Boston Children's Hospital cardiology clinic for outpatient care.
Who cannot join
- Current pregnancy
- Decompensated heart failure/pulmonary edema
- Severe aortic insufficiency
- Active tachyarrhythmias
- Frequent atrial or ventricular ectopy
- Symptomatic peripheral vascular disease
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
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.
Read the 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.
- Conditions
- Single-ventricle, Congenital Heart Disease
- Being tested
- EECP
- Keywords
- Fontan
- Medical subject headings
- Univentricular Heart, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EECPDevice
1 hour of treatment with EECP
| Study group | Role | What they receive |
|---|---|---|
| Enhanced External Counterpulsation (EECP) | Other | 1 hour of treatment with EECP Receives: Device: EECP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cardiac output
Measurement of cardiac output (pulmonary blood flow) in L/min using inert gas rebreathing method (Innocor CO device)
Measured: 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
Measured: 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
Measured: From completion of EECP treatment until patient discharge (30 to 60 minutes)
Secondary outcomes (4)
Change in ventricular strain analysis
Global mid-ventricle circumferential strain (%) and global longitudinal strain (%) calculated from speckle-tracking echocardiography
Measured: 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.
Measured: 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
Measured: pre and 30 minutes post EECP treatment
Total nitrate/nitrite (NOx) levels
This will measure endothelial function
Measured: pre and 30 minutes post EECP treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2021
- Study start31 Mar 2022
- Primary completion17 May 2023
- Study completion17 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Single-ventricleStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fred Wu, MD, Boston Children's Hospital
- Investigators
- Fred Wu, MD, Principal investigator, Attending Cardiologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04956952
- Sponsor's protocol ID
- P00037795
- Status last verified
- Jun 2023
- First submitted
- 1 Jun 2021
- Last updated
- 13 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced External Counterpulsation in Patients With Fontan Circulation
- ClinicalTrials.gov ID
- NCT04956952
- Acronym / sponsor ID
- P00037795
- Conditions
- Single-ventricle, Congenital Heart Disease
- Keywords
- Fontan
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 31 Mar 2022 (actual)
- Primary completion
- 17 May 2023 (actual)
- Study completion
- 17 May 2023 (actual)
- First posted
- 9 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enhanced External Counterpulsation (EECP) | Other | Device: EECP1 hour of treatment with EECP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals with Fontan physiology being seen in the Boston Children's Hospital cardiology clinic for outpatient care.
Key exclusion criteria (11 listed)
- Current pregnancy
- Decompensated heart failure/pulmonary edema
- Severe aortic insufficiency
- Active tachyarrhythmias
- Frequent atrial or ventricular ectopy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EECP1 hour of treatment with EECP | Device | Enhanced External Counterpulsation (EECP) |
Primary outcome
Change in cardiac output
Time frame: 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
Time frame: During EECP treatment (duration 60 minutes)
Adverse events will be collected by an investigator and documented using CTCAE criteria
Total number and type of adverse events immediately following EECP treatment
Time frame: 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
4 secondary outcomes
Change in ventricular strain analysis
Time frame: 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
Time frame: Immediately prior to starting EECP treatment, during each 20-minute phase of EECP treatment, and 30 minutes after EECP treatment
plasma endothelin (ET-1)
Time frame: pre and 30 minutes post EECP treatment
Total nitrate/nitrite (NOx) levels
Time frame: pre and 30 minutes post EECP treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fred Wu, MD principal investigator
Attending Cardiologist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EECP in people with Single-ventricle and Congenital Heart Disease, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cardiac output (time frame: Immediately prior to starting EECP treatment, during each 20-minute phase of EECP treatment, and 30 minutes after EECP treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2023.