Trial Outcomes & Findings for Methacetin Breath Test in Patients With Liver Disease Secondary to Heart Disease (NCT NCT04176458)

Last Updated: 2023-04-05

Results Overview

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.

Recruitment status

TERMINATED

Study phase

Target enrollment

4 participants

Primary outcome timeframe

90 minutes MBT measurement is taken

Results posted on

2023-04-05

Participant Flow

Subjects were recruited from the PI's liver/congenital heart disease clinic. Subjects were given details of the study and an IRB approved ICF to review at home. Those interested were later brought in for study visit. They came to the liver clinic for study procedures.

Participant milestones

Participant milestones
Measure	MBT in Liver Disease Methacetin Breath test (MBT) intervention Methacetin Breath Test (MBT): 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.
Overall Study STARTED	4
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	MBT in Liver Disease Methacetin Breath test (MBT) intervention Methacetin Breath Test (MBT): 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.
Overall Study Covid 19	4

Baseline Characteristics

Analysis not performed as study ended early due to Covid 19 pandemic.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MBT in Liver Disease n=4 Participants Methacetin Breath test (MBT) intervention Methacetin Breath Test (MBT): 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. Results incomplete as we closed the study due to COVID 19 impacting study recruitment at our site.
Age, Categorical <=18 years	0 Participants n=5 Participants • Analysis not performed as study ended early due to Covid 19 pandemic.
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants • Analysis not performed as study ended early due to Covid 19 pandemic.
Age, Categorical >=65 years	0 Participants n=5 Participants • Analysis not performed as study ended early due to Covid 19 pandemic.
Sex: Female, Male Female	3 Participants n=5 Participants • Analysis not performed as study ended early due to Covid 19 pandemic.
Sex: Female, Male Male	1 Participants n=5 Participants • Analysis not performed as study ended early due to Covid 19 pandemic.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants • Analysis not performed as study ended early due to Covid 19 pandemic.
Race (NIH/OMB) Asian	1 Participants n=5 Participants • Analysis not performed as study ended early due to Covid 19 pandemic.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants • Analysis not performed as study ended early due to Covid 19 pandemic.
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants • Analysis not performed as study ended early due to Covid 19 pandemic.
Race (NIH/OMB) White	3 Participants n=5 Participants • Analysis not performed as study ended early due to Covid 19 pandemic.
Race (NIH/OMB) More than one race	0 Participants n=5 Participants • Analysis not performed as study ended early due to Covid 19 pandemic.
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants • Analysis not performed as study ended early due to Covid 19 pandemic.
Region of Enrollment United States	4 participants n=5 Participants • Analysis not performed as study ended early due to Covid 19 pandemic.
Age of participants	36 years STANDARD_DEVIATION 9 • n=5 Participants • Analysis not performed as study ended early due to Covid 19 pandemic.
PDR (%/hr.)	35.5 %/hr. STANDARD_DEVIATION 16.7 • n=5 Participants
time from administration of 13C methacetin to peak elimination of 13CO2 in mins.	23.7 minutes STANDARD_DEVIATION 12.8 • n=5 Participants

PRIMARY outcome

Timeframe: 90 minutes MBT measurement is taken

Population: Per the protocol, 2 MBT tests are required. Due to covid 19 restrictions, subjects could not return for the 2nd test and therefore data analysis could not be performed.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 1 hour for MR elastography

Population: Per protocol, subjects were required to have 2 MBT tests. Due to covid 19 restrictions, subjects could not return to have second required MBT test nor have elastography performed as non-essential procedures were not allowed. This limited enrollment and analysis and therefore, we had to close the study.

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 1 year

Population: Due to covid 19 restrictions subjects did not complete procedures so could not analyze data as per protocol. Note I have to add primary measure above otherwise I get errors. The primary measure could not be analyzed so I am putting 0 in the arms/group and outcome measure table since no analysis.

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.

Outcome measures

Outcome data not reported

Adverse Events

MBT in Liver Disease

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Daniel Ganger, MD

Northwestern University

Phone: 3126954496

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place