Methacetin Breath Test in Patients With Liver Disease Secondary to Heart Disease

NCT04176458 | Terminated Results FDA Device

• 1 other identifier: STU00208318
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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. 3.To determine whether MBT is predictive of clinical outcomes: heart failure, clinically significant ascites, and time to transplant or death.

Conditions

Dilated Cardiomyopathy; Tricuspid Atresia

Outcome Measures

Primary Outcomes (3)

• Methacetin Breath Test Results in Patients Undergoing Heart and Liver Transplant Evaluation.

  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 measures and computes the ratio between 13CO2 and 12CO2 in the patient's exhaled breath. The components of the MBT system include the 1. MBT BreathID® MCS unit; 2. 13C-Methacetin solution. The Cumulative Percent Dose Recovery to be used will be at 20 min (CPDR20) as it correlated with the degree of liver disease severity.

  90 minutes MBT measurement is taken

• MR Elastography Results Compared to Methacetin Breath Test Results in Patients Undergoing Heart and Liver Transplant Evaluation.

  To explore any association between MBT parameter and clinical parameters available. Liver stiffness (using ARFI or MR elastography).

  1 hour for MR elastography

• To Explore Any Association Between MBT Parameter and Clinical Parameters Already Available Per Standard of Care in Patients Undergoing Heart and Liver Transplant Evaluation.

  To explore any association between MBT parameter and clinical Standard of Care parameters, 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., onset of DCM) within 12 months of the study. 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 measures and computes the ratio between 13CO2 and 12CO2 in the patient's exhaled breath. The components of the MBT system include the 1. MBT BreathID® MCS unit; 2. 13C-Methacetin solution.

  1 year

Study Arms (1)

MBT in liver disease

OTHER

Methacetin Breath test (MBT) intervention. We will use the MBT test to measure time from administration of 13C methacetin to obtaining the peak elimination of 13CO2.

Device: Methacetin Breath Test (MBT)

Interventions

Methacetin Breath Test (MBT) DEVICE

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.

MBT in liver disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent obtained prior to any study-specific assessments
• Adults patients ≥ 18 years of age
• Liver disease secondary to congenital heart disease or cardiomyopathy

You may not qualify if:

• Inability to comprehend and/or give informed consent
• Male and female subjects \< 18 years of age
• Females of child-bearing potential that are pregnant or breastfeeding

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• D'Amico G, Garcia-Tsao G, Pagliaro L. Natural history and prognostic indicators of survival in cirrhosis: a systematic review of 118 studies. J Hepatol. 2006 Jan;44(1):217-31. doi: 10.1016/j.jhep.2005.10.013. Epub 2005 Nov 9. No abstract available.

  PMID: 16298014 BACKGROUND

MeSH Terms

Conditions

Cardiomyopathy, Dilated; Tricuspid Atresia

Condition Hierarchy (Ancestors)

Cardiomegaly; Heart Diseases; Cardiovascular Diseases; Cardiomyopathies; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heart Defects, Congenital; Cardiovascular Abnormalities; Heart Valve Diseases; Congenital Abnormalities

Limitations and Caveats

Due to COVID 19 restrictions at our site study could not be completed.

Results Point of Contact

• Title: Daniel Ganger, MD
• Organization: Northwestern University

daniel.ganger@nm.org

3126954496

Study Officials

• Daniel R Ganger, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 12, 2019
• First Posted: November 25, 2019
• Study Start: April 21, 2019
• Primary Completion: March 19, 2021
• Study Completion: March 19, 2021
• Last Updated: April 5, 2023
• Results First Posted: April 5, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)