Liver DiseaseEarly Phase 1NCT02506335
Liver Function Measured by HepQuant-SHUNT in the Prediction of Outcomes in Patients With Heart Disease
A Early Phase 1 study testing Cholate testing in people with Liver Disease and Cardiovascular Disease, run by Northwestern University.
Trial summary
Background: It is still difficult to predict the outcome in patients requiring Fontan Revisions and in those who have evidence of congestive hepatopathy and probable cirrhosis requiring major cardiac surgery including heart transplant. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Liver Disease, Cardiovascular Disease
- What is being tested?
- Cholate testing
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2015to 1 May 2018
- Phase
- Early Phase 1
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent obtained prior to any study-specific assessments.
- Liver disease secondary to congenital heart disease or cardiomyopathy.
- Male and female subjects (age 18 to 70 years of age).
Who cannot join
- Male and female subjects < 18 or > 70 years of age.
- Female subjects of child-bearing potential that are pregnant or breast feeding.
- Subjects on both beta blockers and ACE inhibitors.
About this study
Official title: Liver Function Measured by HepQuant-SHUNT in the Prediction of Outcomes in Patients With Passive Hepatic Congestion Secondary to Congenital Heart Disease (CHD) or Cardiomyopathy
Background: It is still difficult to predict the outcome in patients requiring Fontan Revisions and in those who have evidence of congestive hepatopathy and probable cirrhosis requiring major cardiac surgery including heart transplant. Over the years, many prognostic indices have been derived from laboratory results of blood tests, clinical and physiological variables (or some combination thereof), from liver imaging to liver histology, which has issues of sampling error, medical risks and technical difficulty. None of these have proved entirely satisfactory. Predicting morbidity or survival is particularly important when deciding about Fontan revisions versus the need for heart transplantation. What is needed here is a truly reliable test of liver function that can help predict outcome, on the basis of a single measurement within few days of a planned revision. For this purpose, it is desirable that the chosen tests of liver performance be safe, non-invasive, easy to perform, have a rapid turnaround for results, and be readily repeatable.
Tests of hepatic elimination of various exogenous substances have been described, such as galactose elimination capacity (GEC), indocyanine green (ICG) clearance, lidocaine metabolism to monoethylglycinexylidide (MEGX), and other tests that rely on liver metabolic capacity. None of these metabolic or clearance tests achieved widespread acceptance or use, mostly because their performance and analyses were cumbersome.
HepQuant,LLC has developed a platform of tests of liver function which include Systemic Hepatic Filtration Rate (HFR), Portal HFR, SHUNT, and Disease Severity Index (DSI)1,2. HepQuant tests specifically target the hepatic uptake of cholate and use a single noninvasive test of 90 minutes duration to quantify the systemic circulation, portal circulation, and portal-systemic shunt and to derive a DSI in intact human subjects. HepQuant tests can assess all stages and etiologies of liver disease. In chronic HCV patients HepQuant testing can predict which patients will respond to antiviral therapy and can measure the improvement in hepatic function that occurs after successful antiviral therapy. Patients who did not respond were followed for an average of 5 years and up to 8 years, and baseline HepQuant testing could predict clinical outcomes (CTP progression, variceal bleeding, encephalopathy, ascites, liver-related death) with 87% sensitivity and 71% specificity.
Read the detailed description
Hypothesis The results of HepQuant in patients with CHD will correlate with outcomes of cardiac surgery (namely morbidity as defined by complications such as ischemic hepatitis, survival, need for heart transplantation, improvement of liver function post revision), and thus can be used for prognosis in this condition, either alone or in conjunction with other clinical, physiological, and laboratory prognostic scores, thereby giving clinical guidance concerning the need for heart transplantation and simultaneous liver transplantation..
Primary Aim To assess the relationship between HepQuant testing results and clinical outcomes in patients with liver disease secondary to congenital heart disease (CHD) undergoing Fontan revisions.
To assess the clinical outcomes of patients with liver disease secondary to acquired cardiomyopathy or valvular disease that will undergo extensive heart surgery or heart transplantation.
Secondary Aim To assess whether HepQuant testing predicts clinical outcome in patients with Liver Disease and CHD when used in conjunction with other diagnostic tests, such as MELD, Child-Turcotte-Pugh (CTP), liver stiffness measurement (US with ARFI), and Fibrotest (Fibrosure).
Study population Male and female Subjects (age 18 to 70 years) with liver disease secondary to congenital heart disease or cardiomyopathy.
- Conditions
- Liver Disease, Cardiovascular Disease
- Being tested
- Cholate testing
- Keywords
- Liver disease, cardiomyopathy, congenital heart disease
- Medical subject headings
- Liver Diseases, Cardiovascular Diseases, Cardiomyopathies, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cholate testingDrug
Also called 13C-cholate, d4-cholate
The patient receives simultaneously an oral dose of d4-cholate and an IV dose of 13C-cholate, which are stable isotopes; there is no radioactivity or radiation exposure.
| Study group | Role | What they receive |
|---|---|---|
| Hep quant cholate testing | Other | diagnostic measure of liver function Receives: Drug: Cholate testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver Function
Liver function as measured by HepQuant testing which include Systemic Hepatic Filtration Rate (HFR), Portal HFR, SHUNT.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2015 (estimated)
- Study start1 Sep 2015
- Primary completion1 May 2018
- Study completion1 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Colorado, Denver
- Responsible party
- Principal investigator, Daniel Ganger, Northwestern University
- Investigators
- Daniel Ganger, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02506335
- Sponsor's protocol ID
- STU00100794
- Status last verified
- Aug 2018
- First submitted
- 24 Jun 2015
- Last updated
- 22 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Everson GT, Shiffman ML, Morgan TR, Hoefs JC, Sterling RK, Wagner DA, Kulig CC, Curto TM, Wright EC; Halt-C Trial Group. The spectrum of hepatic functional impairment in compensated chronic hepatitis C: results from the Hepatitis C Anti-viral Long-term Treatment against Cirrhosis Trial. Aliment Pharmacol Ther. 2008 May;27(9):798-809. doi: 10.1111/j.1365-2036.2008.03639.x. Epub 2008 Feb 7.
PubMed 18266997Everson GT, Martucci MA, Shiffman ML, Sterling RK, Morgan TR, Hoefs JC; HALT-C trial group. Portal-systemic shunting in patients with fibrosis or cirrhosis due to chronic hepatitis C: the minimal model for measuring cholate clearances and shunt. Aliment Pharmacol Ther. 2007 Aug 1;26(3):401-10. doi: 10.1111/j.1365-2036.2007.03389.x.
PubMed 17635375
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liver Function Measured by HepQuant-SHUNT in the Prediction of Outcomes in Patients With Passive Hepatic Congestion Secondary to Congenital Heart Disease (CHD) or Cardiomyopathy
- ClinicalTrials.gov ID
- NCT02506335
- Acronym / sponsor ID
- STU00100794
- Conditions
- Liver Disease, Cardiovascular Disease
- Keywords
- Liver disease, cardiomyopathy, congenital heart disease
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- University of Colorado, Denver
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 23 Jul 2015 (estimated)
- 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.
Background: It is still difficult to predict the outcome in patients requiring Fontan Revisions and in those who have evidence of congestive hepatopathy and probable cirrhosis requiring major cardiac surgery including heart transplant. Over the years, many prognostic indices have been derived from laboratory results of blood tests, clinical and physiological variables (or some combination thereof), from liver imaging to liver histology, which has issues of sampling error, medical risks and technical difficulty. None of these have proved entirely satisfactory. Predicting morbidity or survival is particularly important when deciding about Fontan revisions versus the need for heart transplantation. What is needed here is a truly reliable test of liver function that can help predict outcome, on the basis of a single measurement within few days of a planned revision. For this purpose, it is desirable that the chosen tests of liver performance be safe, non-invasive, easy to perform, have a rapid turnaround for results, and be readily repeatable.
Tests of hepatic elimination of various exogenous substances have been described, such as galactose elimination capacity (GEC), indocyanine green (ICG) clearance, lidocaine metabolism to monoethylglycinexylidide (MEGX), and other tests that rely on liver metabolic capacity. None of these metabolic or clearance tests achieved widespread acceptance or use, mostly because their performance and analyses were cumbersome.
HepQuant,LLC has developed a platform of tests of liver function which include Systemic Hepatic Filtration Rate (HFR), Portal HFR, SHUNT, and Disease Severity Index (DSI)1,2. HepQuant tests specifically target the hepatic uptake of cholate and use a single noninvasive test of 90 minutes duration to quantify the systemic circulation, portal circulation, and portal-systemic shunt and to derive a DSI in intact human subjects. HepQuant tests can assess all stages and etiologies of liver disease. In chronic HCV patients HepQuant testing can predict which patients will respond to antiviral therapy and can measure the improvement in hepatic function that occurs after successful antiviral therapy. Patients who did not respond were followed for an average of 5 years and up to 8 years, and baseline HepQuant testing could predict clinical outcomes (CTP progression, variceal bleeding, encephalopathy, ascites, liver-related death) with 87% sensitivity and 71% specificity.
Detailed description
Hypothesis The results of HepQuant in patients with CHD will correlate with outcomes of cardiac surgery (namely morbidity as defined by complications such as ischemic hepatitis, survival, need for heart transplantation, improvement of liver function post revision), and thus can be used for prognosis in this condition, either alone or in conjunction with other clinical, physiological, and laboratory prognostic scores, thereby giving clinical guidance concerning the need for heart transplantation and simultaneous liver transplantation..
Primary Aim To assess the relationship between HepQuant testing results and clinical outcomes in patients with liver disease secondary to congenital heart disease (CHD) undergoing Fontan revisions.
To assess the clinical outcomes of patients with liver disease secondary to acquired cardiomyopathy or valvular disease that will undergo extensive heart surgery or heart transplantation.
Secondary Aim To assess whether HepQuant testing predicts clinical outcome in patients with Liver Disease and CHD when used in conjunction with other diagnostic tests, such as MELD, Child-Turcotte-Pugh (CTP), liver stiffness measurement (US with ARFI), and Fibrotest (Fibrosure).
Study population Male and female Subjects (age 18 to 70 years) with liver disease secondary to congenital heart disease or cardiomyopathy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hep quant cholate testing | Other | Drug: Cholate testingdiagnostic measure of liver function |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Written informed consent obtained prior to any study-specific assessments.
- Liver disease secondary to congenital heart disease or cardiomyopathy.
- Male and female subjects (age 18 to 70 years of age).
Key exclusion criteria (3 listed)
- Male and female subjects < 18 or > 70 years of age.
- Female subjects of child-bearing potential that are pregnant or breast feeding.
- Subjects on both beta blockers and ACE inhibitors.
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 testingAlso: 13C-cholate, d4-cholateThe patient receives simultaneously an oral dose of d4-cholate and an IV dose of 13C-cholate, which are stable isotopes; there is no radioactivity or radiation exposure. | Drug | Hep quant cholate testing |
Primary outcome
Liver Function
Time frame: 6 months
Liver function as measured by HepQuant testing which include Systemic Hepatic Filtration Rate (HFR), Portal HFR, SHUNT.
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 22 Aug 2018.
- Background: PubMed 18266997Everson GT, Shiffman ML, Morgan TR, Hoefs JC, Sterling RK, Wagner DA, Kulig CC, Curto TM, Wright EC; Halt-C Trial Group. The spectrum of hepatic functional impairment in compensated chronic hepatitis C: results from the Hepatitis C Anti-viral Long-term Treatment against Cirrhosis Trial. Aliment Pharmacol Ther. 2008 May;27(9):798-809. doi: 10.1111/j.1365-2036.2008.03639.x. Epub 2008 Feb 7.
- Results publication: PubMed 17635375Everson GT, Martucci MA, Shiffman ML, Sterling RK, Morgan TR, Hoefs JC; HALT-C trial group. Portal-systemic shunting in patients with fibrosis or cirrhosis due to chronic hepatitis C: the minimal model for measuring cholate clearances and shunt. Aliment Pharmacol Ther. 2007 Aug 1;26(3):401-10. doi: 10.1111/j.1365-2036.2007.03389.x.
- 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.
Daniel Ganger, MD principal investigator
Northwestern University
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Cholate testing in people with Liver Disease and Cardiovascular Disease, run by Northwestern University.
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 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 22 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Liver Function (time frame: 6 months). 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 NCT02506335, which also lists 2 linked publications.
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 22 Aug 2018.