FontanNCT07009132
Cholate Clearance in Fontan and Heart Failure
An observational study of Fontan and Right Heart Failure, run by HepQuant, LLC at 1 site in United States.
Trial summary
The goal of this study is to use the HepQuant dual cholate clearance assay, which has been shown to measure liver function in people with known chronic liver conditions, to assess severity of Fontan-associated liver disease (FALD). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fontan, Right Heart Failure
- What is being tested?
- Dual cholate clearance assay and MRI
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device, Surgery or procedure
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Aug 2025to Dec 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Eligible Fontan participants will be identified by screening the Fontan database for patients who have undergone cardiac catheterization in the past year and by searching the outpatient clinic schedule. Eligible RHF and normal control participants will be screened through the outpatient echo lab schedule at Hospital of the University of Pennsylvania.
Who may be able to join
- Fontan: Adult Fontan patients ≥ 18 years of age who have undergone right heart catheterization within the past 1 year.
- RHF Controls: non-Fontan adults with two ventricle anatomy with systemic left ventricle, CVP estimate ≥ 8 mmHg and left ventricle (LV) function ≥ 50% by echocardiogram performed within the past 1 year. Can include those with congenital heart disease- repaired or unrepaired.
- Normal Controls: non-Fontan adults with normal cardiac anatomy, normal biventricular function, < moderate tricuspid regurgitation and CVP estimate < 5 mmHg by echocardiogram performed within the past 1 year.
Who cannot join
- Pregnant or breastfeeding
- Unable to comprehend and/or give informed consent
- Sensitivity to human serum albumin, or its preparations
- Participants with extensive resection of large segments of the small intestine (short gut) or severe gastroparesis
- Participants on non-selective beta blockers, angiotensin converting-enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), ursodeoxycholic acid, cholic acid, or other bile acids who are unwilling or unable to delay taking their normal dose the morning of their dual cholate clearance testing.
- Participants on dietary supplements, bile acid sequestrants, GLP-1 agonists, narcotics, and other medications affecting gastric emptying or intestinal absorption who are unwilling or unable to delay taking or withhold as outlined in the instructions on deviating from the SHUNT test.
- Contraindication to cardiac MRI
- For RHF and normal controls: diabetes, chronic liver disease, >moderate alcohol use, BMI >30, oxygen-dependent, pulmonary hypertension22 on therapy, known porto-pulmonary hypertension
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Bella Clinical Research Coordinator, 215-615-3388, Isabella.Farkas@Pennmedicine.upenn.edu
Yuli Kim, MD
About this study
Official title: Hepatic Perfusion and Liver Health as Assessed by Dual Cholate Clearance Assay in Fontan-associated Liver Disease (FALD)
The goal of this study is to use the HepQuant dual cholate clearance assay, which has been shown to measure liver function in people with known chronic liver conditions, to assess severity of Fontan-associated liver disease (FALD).
This study aims to understand the role impaired blood flow to the liver plays in liver function in Fontan patients compared to patients with right heart failure and healthy controls. The study will also determine whether cholate clearance is a good measure to use in this population, and whether it will be able to predict clinical outcomes.
Participants will undergo a HepQuant dual cholate clearance assay and a cardiac magnetic resonance imaging (MRI) at the beginning of the study, and then data on health status will be collected for 5 years.
- Conditions
- Fontan, Right Heart Failure
- Being tested
- Dual cholate clearance assay, MRI
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual cholate clearance assayDevice
Also called HepQuant dual cholate clearance assay
Study participants are administered labeled oral and intravenous cholate, and then two blood samples are taken over 60-minutes. Serum cholate levels are measured by blood draws.
MRIRadiation
Unsedated non contrast cardiac magnetic resonance imaging (MRI)
| Study group | Role | What they receive |
|---|---|---|
| Fontan | Patients with a Fontan diagnosis who have undergone a right heart catheterization in the past year Receives: Device: Dual cholate clearance assay; Radiation: MRI | |
| Right Heart Failure (RHF) Controls | Non-Fontan patients with RHF (patients with normal 2-ventricle anatomy who have intermediate or elevated right-sided filling pressures (CVP) by echocardiogram) Receives: Device: Dual cholate clearance assay; Radiation: MRI | |
| Normal Controls | Patients with normal cardiac anatomy and normal CVP (right-sided filling pressure) by echocardiogram. Receives: Device: Dual cholate clearance assay; Radiation: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepatic cholate clearance
13C-cholate and d4-cholate clearance as assessed by the dual cholate clearance test
Measured: Baseline
Secondary outcomes (1)
Occurrence of at Least One Heart or Liver-Related Clinical Outcome
A patient will be considered to have a heart or liver-related clinical outcome if any of the following occur within 5 years after the first cholate assay: new-onset heart failure (defined as hospitalization for intravenous diuresis), progressive heart failure (defined as referral for heart or combined heart-liver transplant), clinically significant ascites (defined as requiring large volume paracentesis), new-onset protein-losing enteropathy, hepatocellular carcinoma, heart transplant or a combined heart and liver transplant, or death. Number of subjects with at least one of the above clinical outcomes will be captured and reported for all study groups.
Measured: 5 years after first cholate assay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start4 Aug 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FontanStudies of the same condition, open and under way.
- 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
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HepQuant, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Pennsylvania
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07009132
- Sponsor's protocol ID
- Fontan Cholate 2.0
- Status last verified
- Sep 2025
- First submitted
- 20 May 2025
- Last updated
- 17 Sep 2026
- 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 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatic Perfusion and Liver Health as Assessed by Dual Cholate Clearance Assay in Fontan-associated Liver Disease (FALD)
- ClinicalTrials.gov ID
- NCT07009132
- Acronym / sponsor ID
- Fontan Cholate 2.0
- Conditions
- Fontan, Right Heart Failure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- HepQuant, LLCIndustry (pharma, biotech, devices)
- Collaborators
- University of Pennsylvania
- Study start
- 4 Aug 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 6 Jun 2025 (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 goal of this study is to use the HepQuant dual cholate clearance assay, which has been shown to measure liver function in people with known chronic liver conditions, to assess severity of Fontan-associated liver disease (FALD).
This study aims to understand the role impaired blood flow to the liver plays in liver function in Fontan patients compared to patients with right heart failure and healthy controls. The study will also determine whether cholate clearance is a good measure to use in this population, and whether it will be able to predict clinical outcomes.
Participants will undergo a HepQuant dual cholate clearance assay and a cardiac magnetic resonance imaging (MRI) at the beginning of the study, and then data on health status will be collected for 5 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fontan | – | Device: Dual cholate clearance assay, Radiation: MRIPatients with a Fontan diagnosis who have undergone a right heart catheterization in the past year |
| Right Heart Failure (RHF) Controls | – | Device: Dual cholate clearance assay, Radiation: MRINon-Fontan patients with RHF (patients with normal 2-ventricle anatomy who have intermediate or elevated right-sided filling pressures (CVP) by echocardiogram) |
| Normal Controls | – | Device: Dual cholate clearance assay, Radiation: MRIPatients with normal cardiac anatomy and normal CVP (right-sided filling pressure) by echocardiogram. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible Fontan participants will be identified by screening the Fontan database for patients who have undergone cardiac catheterization in the past year and by searching the outpatient clinic schedule. Eligible RHF and normal control participants will be screened through the outpatient echo lab schedule at Hospital of the University of Pennsylvania.
Key inclusion criteria (3 listed)
- Fontan: Adult Fontan patients ≥ 18 years of age who have undergone right heart catheterization within the past 1 year.
- RHF Controls: non-Fontan adults with two ventricle anatomy with systemic left ventricle, CVP estimate ≥ 8 mmHg and left ventricle (LV) function ≥ 50% by echocardiogram performed within the past 1 year. Can include those with congenital heart disease- repaired or unrepaired.
- Normal Controls: non-Fontan adults with normal cardiac anatomy, normal biventricular function, < moderate tricuspid regurgitation and CVP estimate < 5 mmHg by echocardiogram performed within the past 1 year.
Key exclusion criteria (8 listed)
- Pregnant or breastfeeding
- Unable to comprehend and/or give informed consent
- Sensitivity to human serum albumin, or its preparations
- Participants with extensive resection of large segments of the small intestine (short gut) or severe gastroparesis
- Participants on non-selective beta blockers, angiotensin converting-enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), ursodeoxycholic acid, cholic acid, or other bile acids who are unwilling or unable to delay taking their normal dose the morning of their dual cholate clearance testing.
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 |
|---|---|---|
| Dual cholate clearance assayAlso: HepQuant dual cholate clearance assayStudy participants are administered labeled oral and intravenous cholate, and then two blood samples are taken over 60-minutes. Serum cholate levels are measured by blood draws. | Device | Fontan, Normal Controls, Right Heart Failure (RHF) Controls |
| MRIUnsedated non contrast cardiac magnetic resonance imaging (MRI) | Radiation | Fontan, Normal Controls, Right Heart Failure (RHF) Controls |
Primary outcome
Hepatic cholate clearance
Time frame: Baseline
13C-cholate and d4-cholate clearance as assessed by the dual cholate clearance test
1 secondary outcome
Occurrence of at Least One Heart or Liver-Related Clinical Outcome
Time frame: 5 years after first cholate assay
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- 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.
Hospital of the University of Pennsylvania
Philadelphia, United States
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 and Right Heart Failure, run by HepQuant, LLC 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 8 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: looking for participants now, as of the sponsor's last update on 17 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hepatic cholate clearance (time frame: Baseline). 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 17 Sep 2026.