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NCT04176458 · ClinicalTrials.gov registry record · NA
Methacetin Breath Test in Patients With Liver Disease Secondary to Heart Disease
A NA study, sponsored by Northwestern University.
- Terminated
- Registry status
- NA
- Development phase
- 4
- Enrollment target
NCT04176458: Clinical Trial NA study, sponsored by Northwestern University.
NCT04176458 is a NA study that was terminated before completion, run by Northwestern University. The registered enrollment target is 4 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04176458, a NA study, was terminated before completion, sponsored by Northwestern University.
- TERMINATED
- Registry status
- NA
- Development phase
- 4 participants
- Enrollment target
Study Summary
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.
Primary Outcome
1\. To perform methacetin breath tests (MBT) in a cohort of patients with Congestive (Dilated) Cardiomyopathy and a group of Fontan patients and compare results of the methacetin breath tests to published normal controls. The ¹³C-Methacetin Breath Test (MBT) is a non-invasive test for assessing liver metabolic function. The BreathID® MCS System consists of the BreathID® MCS device and a test kit containing a breath collection cannula and a non-radioactive isotope 13C-Methacetin solution. It meas
Interventions
- DEVICE Methacetin Breath Test (MBT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2019-04-21 |
| Est. Completion | 2021-03-19 |
| Phase | NA |
Why NCT04176458 stopped before completion
NCT04176458 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 1 intervention - of which Methacetin Breath Test (MBT) is the first listed.
NCT04176458 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04176458 about?
NCT04176458 is a clinical study titled "Methacetin Breath Test in Patients With Liver Disease Secondary to Heart Disease". 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 rel...
What is the current status of trial NCT04176458?
This trial is currently terminated. It is a NA study. The enrollment target is 4 participants. The study started on 2019-04-21. Estimated completion is 2021-03-19.
What interventions are being tested in trial NCT04176458?
The interventions under investigation include: Methacetin Breath Test (MBT) (DEVICE).
Who is sponsoring clinical trial NCT04176458?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04176458's enrollment target sits among peer trials
4 1996th of 2000 higher than 5 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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