Methacetin Breath Test in Patients With Liver Disease Secondary to Heart Disease
Public ClinicalTrials.gov record NCT04176458. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Non-invasive Assessment of Liver Function in Patients Undergoing Heart and Liver Transplant Evaluation
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The aim of this project is assess a non-invasive functional liver tests in patients with the Fontan circulation that may be used for prognostic purposes. Specifically, we aim to determine whether there are alterations in Methacetin Breath Test (MBT) in the Fontan patient and if so, whether it is related to conventional tests of liver and cardiac function. The hypothesis is that MBT CPDR 20 in the Fontan patient is abnormal as a result of alterations in liver perfusion, liver cell metabolic capability and transhepatic resistance secondary to hemodynamics unique to the Fontan as well as end-organ liver damage. Due to lack of robust biomarkers or other risk stratification schemes, we aim to determine whether there is prognostic value in hepatic MBT CPDR 20 in the Fontan patient. Aims - The aims of this study are three-fold: 1. To measure MBT parameter in a cohort of patients with Congestive (Dilated) Cardiomyopathy and a group of Fontan patients and compare results to published normal controls. 2. To explore any association between MBT parameter and clinical parameters already available, including Fontan hemodynamics as assessed by either of the following tests: cardiac catheterization, echocardiography, non-invasive imaging of the liver (CT or MRI), non-invasive assessment of liver stiffness (ARFI, MRE or Fibroscan), laboratory investigations, and clinical characteristics (i.e. age of patient, time since Fontan operation, type of Fontan etc.) within 12 months of the study. 3. To determine whether MBT is predictive of clinical outcomes: heart failure, clinically significant ascites, and time to transplant or death.
Study identification
- NCT ID
- NCT04176458
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 4 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 20, 2019
- Primary completion
- Mar 18, 2021
- Completion
- Mar 18, 2021
- Last update posted
- Apr 4, 2023
2019 – 2021
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Northwestern | Chicago | Illinois | 60611 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04176458, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 4, 2023 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04176458 live on ClinicalTrials.gov.