Single-ventricleNCT03481985
The Effect of Fontan Fenestration Closure on Hepatic Stiffness
An observational study of Single-ventricle and Hepatic Congestion, run by Boston Children's Hospital at 1 site in United States.
Trial summary
The overarching goal of this project is to discern how closure of Fontan fenestrations in patients with single ventricle heart disease will affect hepatic congestion, a major determinant of chronic liver disease. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Single-ventricle, Hepatic Congestion
- What is being tested?
- Fenestration status
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 29 May 2018to 30 Jun 2022
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Any functional single-ventricle patients undergoing catheterization for Fontan fenestration closure will be invited to participate.
Who may be able to join
- Functional Single ventricle patients after a fenestrated lateral tunnel or extra-cardiac Fontan
- Patients scheduled for possible fenestration closure in the catheterization laboratory
- Informed consent has been obtained
Who cannot join
- Patients with spontaneous closure of Fenestration
- Ascites
- Ventilatory requirement
- Implantable cardiac device
- Ongoing inotropic support
- Pregnancy
- Inability to tolerate four hour pre-procedure fasting
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
The overarching goal of this project is to discern how closure of Fontan fenestrations in patients with single ventricle heart disease will affect hepatic congestion, a major determinant of chronic liver disease. We will employ transient elastography (Fibroscan) to obtain liver stiffness measurements (LSM) before and after fenestration closure to study the impact of this intervention on hepatic congestion.
Read the detailed description
Methods Eligible patients will be contacted in advance of hospitalization for catheterized fenestration closure to introduce goals of study and review risks and benefits of participation. At the time of catheterization, the study objectives and consent forms will be explained, allowing sufficient time for questions. To ensure full comprehension of the study, the parent or guardian will be asked to describe his or her participation in the trial.
Using the Fibroscan (Echosens, Paris, France), a transient elastography device, a liver stiffness measurement (LSM) will be obtained prior to the catheterization. On the post-catheterization day, a repeat measurement will be obtained. Transient elastography will be performed by trained study investigators who were certified by the manufacturer.
To obtain an LSM, the appropriate-sized Fibroscan probe must be selected and then aimed in the right upper quadrant space through an intercostal space. For patients with heterotaxy or situs inversus, adjustments in probe positioning may be needed to obtain reliable measurement. Probe selection (small, medium, or large) will be directed by manufacturer guidelines, based on thoracic perimeter.
The operator is guided by an image to locate an appropriate section of liver. The Fibroscan device transmits an elastic shear wave through the hepatic parenchyma and then measures the propagation of the wave through a known distance of liver tissue to calculate a transmission velocity. Using the shear velocity and the mass density of the liver parenchyma, the principles of Young's modulus are invoked to estimate the Elasticity of the tissue. The elasticity is summarized as a liver stiffness measurement (LSM), which is a continuous variable that is reported in kilopascals (kPa). Each LSM outcome value is based on a minimum of ten valid assessments measured in succession. The validity of each individual measurement is determined by the device and the interquartile range of the measurements should fall within 30% of the median LSM. The Fibroscan data collection method is non-invasive and efficient. LSM will be obtained after fasting for a minimum of three hours and without administration of sedating agents/anesthetics.
- Conditions
- Single-ventricle, Hepatic Congestion
- Being tested
- Fenestration status
- Keywords
- Fontan-associated liver disease
- Medical subject headings
- Univentricular Heart
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fenestration statusOther
The exposure variable will be status of the Fontan fenestration
What is being measured
The primary outcome is the main question the study is designed to answer.
Immediate change in liver stiffness
Immediate change in Liver stiffness measurement (measured by Transient Elastography)he first measurement will be obtained on the day of the catheterization (for fenestration closure). The second measurement will be post-fenestration closure and will be obtained on the day after the catheterization.
Measured: Patients will have measurements on day of catheterization and day after catheterization. They will be followed through study completion, an average of 6 months.
Secondary outcomes (1)
Short term change in liver stiffness
Short term change in Liver stiffness measurement (measured by Transient Elastography). The first measurement will be obtained on the day of the catheterization (for fenestration closure). The long-term outcome measurement will be obtained three months after the catheterization procedure.
Measured: The first measurement will be obtained on the day of the catheterization (for fenestration closure). The long-term outcome measurement will be obtained three months afterwards. They will be followed through study completion, an average of 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start29 May 2018
- Primary completion30 Jun 2021
- Study completion30 Jun 2022
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rahul Rathod, Boston Children's Hospital
- Investigators
- Rahul Rathod, MD, Principal investigator, Cardiologist/Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03481985
- Sponsor's protocol ID
- IRB-P00027110
- Status last verified
- Apr 2023
- First submitted
- 7 Mar 2018
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Fontan Fenestration Closure on Hepatic Stiffness
- ClinicalTrials.gov ID
- NCT03481985
- Acronym / sponsor ID
- IRB-P00027110
- Conditions
- Single-ventricle, Hepatic Congestion
- Keywords
- Fontan-associated liver disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 29 May 2018 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 29 Mar 2018 (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 overarching goal of this project is to discern how closure of Fontan fenestrations in patients with single ventricle heart disease will affect hepatic congestion, a major determinant of chronic liver disease. We will employ transient elastography (Fibroscan) to obtain liver stiffness measurements (LSM) before and after fenestration closure to study the impact of this intervention on hepatic congestion.
Detailed description
Methods Eligible patients will be contacted in advance of hospitalization for catheterized fenestration closure to introduce goals of study and review risks and benefits of participation. At the time of catheterization, the study objectives and consent forms will be explained, allowing sufficient time for questions. To ensure full comprehension of the study, the parent or guardian will be asked to describe his or her participation in the trial.
Using the Fibroscan (Echosens, Paris, France), a transient elastography device, a liver stiffness measurement (LSM) will be obtained prior to the catheterization. On the post-catheterization day, a repeat measurement will be obtained. Transient elastography will be performed by trained study investigators who were certified by the manufacturer.
To obtain an LSM, the appropriate-sized Fibroscan probe must be selected and then aimed in the right upper quadrant space through an intercostal space. For patients with heterotaxy or situs inversus, adjustments in probe positioning may be needed to obtain reliable measurement. Probe selection (small, medium, or large) will be directed by manufacturer guidelines, based on thoracic perimeter.
The operator is guided by an image to locate an appropriate section of liver. The Fibroscan device transmits an elastic shear wave through the hepatic parenchyma and then measures the propagation of the wave through a known distance of liver tissue to calculate a transmission velocity. Using the shear velocity and the mass density of the liver parenchyma, the principles of Young's modulus are invoked to estimate the Elasticity of the tissue. The elasticity is summarized as a liver stiffness measurement (LSM), which is a continuous variable that is reported in kilopascals (kPa). Each LSM outcome value is based on a minimum of ten valid assessments measured in succession. The validity of each individual measurement is determined by the device and the interquartile range of the measurements should fall within 30% of the median LSM. The Fibroscan data collection method is non-invasive and efficient. LSM will be obtained after fasting for a minimum of three hours and without administration of sedating agents/anesthetics.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Any functional single-ventricle patients undergoing catheterization for Fontan fenestration closure will be invited to participate.
Key inclusion criteria (3 listed)
- Functional Single ventricle patients after a fenestrated lateral tunnel or extra-cardiac Fontan
- Patients scheduled for possible fenestration closure in the catheterization laboratory
- Informed consent has been obtained
Key exclusion criteria (7 listed)
- Patients with spontaneous closure of Fenestration
- Ascites
- Ventilatory requirement
- Implantable cardiac device
- Ongoing inotropic support
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 |
|---|---|---|
| Fenestration statusThe exposure variable will be status of the Fontan fenestration | Other | – |
Primary outcome
Immediate change in liver stiffness
Time frame: Patients will have measurements on day of catheterization and day after catheterization. They will be followed through study completion, an average of 6 months.
Immediate change in Liver stiffness measurement (measured by Transient Elastography)he first measurement will be obtained on the day of the catheterization (for fenestration closure). The second measurement will be post-fenestration closure and will be obtained on the day after the catheterization.
1 secondary outcome
Short term change in liver stiffness
Time frame: The first measurement will be obtained on the day of the catheterization (for fenestration closure). The long-term outcome measurement will be obtained three months afterwards. They will be followed through study completion, an average of 6 months.
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 19 Apr 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.
Rahul Rathod, MD principal investigator
Cardiologist/Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Single-ventricle and Hepatic Congestion, 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 3 inclusion and 7 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 19 Apr 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?
Immediate change in liver stiffness (time frame: Patients will have measurements on day of catheterization and day after catheterization. They will be followed through study completion, an average of 6 months.). 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 19 Apr 2023.