Fontan ProcedureNCT03726229
Cholate Clearance in Fontans
An observational study of Fontan Procedure, run by University of Pennsylvania at 1 site in United States.
Trial summary
HepQuant is an assay to measure liver function in other forms of liver disease such as hepatitis C. It measures the ability of the liver to process an naturally occurring substance called cholate and has been shown to predict clinical outcomes in some patient populations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fontan Procedure
- What is being tested?
- Cholate assay
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2019to 25 May 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult Fontan survivors at least 18 years of age
Who may be able to join
- s/p Fontan operation
- cardiac catheterization or cardiac MRI within 1 year of enrollment
Who cannot join
- pregnant or breastfeeding
- unable to comprehend and/or give informed consent
- sensitivity to human serum albumin, or its preparations
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Development of a Reliable Means for Functional Assessment of Liver Performance After the Fontan Operation: Dual Cholate Clearance Assay
HepQuant is an assay to measure liver function in other forms of liver disease such as hepatitis C. It measures the ability of the liver to process an naturally occurring substance called cholate and has been shown to predict clinical outcomes in some patient populations.
The Fontan survivor is a patient who has undergone surgery or a series of surgeries that result in a functional single ventricle. The liver is particularly vulnerable to disease including congestion, fibrosis, and even cirrhosis. Currently liver function in the Fontan is not well-characterized and the HepQuant assay could help answer this question.
Read the detailed description
A novel test called HepQuant® is an assay that has been used to measure liver function in other types of liver disease. In these populations, it is hoped that the assay may show more subtle or sub-clinical liver abnormalities that blood tests alone cannot detect. HepQuant® is a test that examines the ability of the liver to process a substance called cholate, which is a naturally occurring substance in the body. Cholate gets to the liver 2 ways: through the gut (by mouth) or through the blood (IV or intravenous). The test involves administering oral and IV cholate which is labeled. This label is NOT radioactive, but can act as an indicator/marker for evaluation purposes.
The purpose of this study is to develop a reliable means of measuring liver function in the Fontan survivor by examining cholate clearance. The investigators aim to 1) explore any association between level of cholate clearance and measurement of heart and liver function and 2) determine whether cholate clearance can predict clinical outcomes such as heart failure, ascites (development of fluid in the abdomen which can result from heart failure or liver failure), and need for heart transplant.
- Conditions
- Fontan Procedure
- Being tested
- Cholate assay
- Keywords
- liver disease
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cholate assayDevice
Also called HepQuant assay
Labeled oral and IV cholate will be administered once to the Fontan cohort and blood specimens will be collected at baseline and timepoints thereafter.
| Study group | Role | What they receive |
|---|---|---|
| Fontan patient | Cholate assay will be administered once to Fontan patients and blood specimens will be collected to analyze cholate clearance. Receives: Device: Cholate assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepatic cholate clearance
D4-cholate and 13C-cholate clearance
Measured: Through study completion, an average of 1 year
Secondary outcomes (1)
Incidence of adverse clinical outcomes
combined outcome of occurrence of any of the following: heart failure admission, clinically significant ascites, protein losing enteropathy, referral for cardiac transplantation, death
Measured: 5 years after cholate assay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2018
- Study start1 May 2019
- Primary completion25 May 2022
- Study completion25 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fontan ProcedureStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yuli Kim, MD, Principal investigator, University of PennsylvaniaMaarouf Hoteit, MD, Principal investigator, Hospital of the University of Pennslyvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03726229
- Sponsor's protocol ID
- 829578
- Status last verified
- Jun 2022
- First submitted
- 29 Oct 2018
- Last updated
- 10 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: IPD will not be shared with other researchers
Publications
Kim YY, Nyman A, Huang YS, Tomlinson AZ, McRae MP, Everson GT, Vaikunth S, Rosenthal B, Rychik J, Hoteit MA. Alterations in Liver Perfusion in Adults With Fontan Circulation as Assessed by Dual Cholate Clearance. J Am Heart Assoc. 2025 Apr;14(7):e039479. doi: 10.1161/JAHA.124.039479. Epub 2025 Mar 21.
PubMed 40118791
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Reliable Means for Functional Assessment of Liver Performance After the Fontan Operation: Dual Cholate Clearance Assay
- ClinicalTrials.gov ID
- NCT03726229
- Acronym / sponsor ID
- 829578
- Conditions
- Fontan Procedure
- Keywords
- liver disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 25 May 2022 (actual)
- Study completion
- 25 May 2022 (actual)
- First posted
- 31 Oct 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.
HepQuant is an assay to measure liver function in other forms of liver disease such as hepatitis C. It measures the ability of the liver to process an naturally occurring substance called cholate and has been shown to predict clinical outcomes in some patient populations.
The Fontan survivor is a patient who has undergone surgery or a series of surgeries that result in a functional single ventricle. The liver is particularly vulnerable to disease including congestion, fibrosis, and even cirrhosis. Currently liver function in the Fontan is not well-characterized and the HepQuant assay could help answer this question.
Detailed description
A novel test called HepQuant® is an assay that has been used to measure liver function in other types of liver disease. In these populations, it is hoped that the assay may show more subtle or sub-clinical liver abnormalities that blood tests alone cannot detect. HepQuant® is a test that examines the ability of the liver to process a substance called cholate, which is a naturally occurring substance in the body. Cholate gets to the liver 2 ways: through the gut (by mouth) or through the blood (IV or intravenous). The test involves administering oral and IV cholate which is labeled. This label is NOT radioactive, but can act as an indicator/marker for evaluation purposes.
The purpose of this study is to develop a reliable means of measuring liver function in the Fontan survivor by examining cholate clearance. The investigators aim to 1) explore any association between level of cholate clearance and measurement of heart and liver function and 2) determine whether cholate clearance can predict clinical outcomes such as heart failure, ascites (development of fluid in the abdomen which can result from heart failure or liver failure), and need for heart transplant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fontan patient | – | Device: Cholate assayCholate assay will be administered once to Fontan patients and blood specimens will be collected to analyze cholate clearance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult Fontan survivors at least 18 years of age
Key inclusion criteria (2 listed)
- s/p Fontan operation
- cardiac catheterization or cardiac MRI within 1 year of enrollment
Key exclusion criteria (3 listed)
- pregnant or breastfeeding
- unable to comprehend and/or give informed consent
- sensitivity to human serum albumin, or its preparations
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 |
|---|---|---|
| Cholate assayAlso: HepQuant assayLabeled oral and IV cholate will be administered once to the Fontan cohort and blood specimens will be collected at baseline and timepoints thereafter. | Device | Fontan patient |
Primary outcome
Hepatic cholate clearance
Time frame: Through study completion, an average of 1 year
D4-cholate and 13C-cholate clearance
1 secondary outcome
Incidence of adverse clinical outcomes
Time frame: 5 years after cholate assay
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 10 Jun 2022.
- Derived from this study: PubMed 40118791Kim YY, Nyman A, Huang YS, Tomlinson AZ, McRae MP, Everson GT, Vaikunth S, Rosenthal B, Rychik J, Hoteit MA. Alterations in Liver Perfusion in Adults With Fontan Circulation as Assessed by Dual Cholate Clearance. J Am Heart Assoc. 2025 Apr;14(7):e039479. doi: 10.1161/JAHA.124.039479. Epub 2025 Mar 21.
- Individual participant dataSharing planned: No. IPD will not be shared with other researchers
Related trials for Fontan Procedure
Not yet recruitingObservational study
A Simple Method for Monitoring the End-organ Function in Patients With Fontan Circulation.
Fontan Procedure, Fontan Circulation
RecruitingObservational study
Pulmonary Determinants of Cardiorespiratory Fitness in Fontan Patients
Fontan Procedure, Congenital Heart Disease
RecruitingPhase 3
Study of Tadalafil vs. Placebo for Improving Hemodynamics and End-Organ Dysfunction in Fontan Physiology
Fontan Palliation
RecruitingPhase 4
The Effect of Dapagliflozin on Exercise and Cardiac Functional Status of Patients After Fontan Procedure
Fontan, Heart Failure
Active, not recruitingObservational study
An Observational Study to Learn More About How Safe Rivaroxaban is And How Well it Works in Children With Congenital Heart Disease Who Had a Heart Surgery Called the Fontan Procedure
Prevention of Venous Thromboembolism, Congenital Heart Disease
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.
Yuli Kim, MD principal investigator
University of Pennsylvania
Maarouf Hoteit, MD principal investigator
Hospital of the University of Pennslyvania
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 Fontan Procedure, run by University of Pennsylvania 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 2 inclusion and 3 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 10 Jun 2022. 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?
Hepatic cholate clearance (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03726229, which also lists 1 linked publication.
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 10 Jun 2022.