Non-invasive Assessment of Liver Function in Patients Undergoing Heart and Liver Transplant Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- MR Elastography Results Compared to Methacetin Breath Test Results in Patients Undergoing Heart and Liver Transplant Evaluation.
研究概览
简要总结
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:
- 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.
- 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.
- To determine whether MBT is predictive of clinical outcomes: heart failure, clinically significant ascites, and time to transplant or death.
详细描述
Research Design and Methods Study Design: This is a prospective pilot cohort study in 20 patients with Dilated Congestive Cardiomyopathy (10) and a group of adult Fontan (10) recruited from an adult congenital heart disease clinic in a tertiary care center. Patients enrolled in the study will be prospectively followed for 3-5 years.
Study Timelines: We anticipate that it will take approximately 2 years to recruit patients who are to be included in this study. Patient will followed 3-5 years. However due to covid 19 issues recruitment did not go as planned and due to this delay we had to end study early. Since study terminated early, subjects will not be followed 3-5 years.
Study Endpoints: 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.
PROCEDURES INVOLVED:
Methods Screening and consent Eligible patients will be screened and recruited through the outpatient Hepatology Clinic, Heart Failure Clinic and the Adult congenital heart disease clinic. They will be approached the day of the scheduled outpatient appointment by the PI or a study coordinator in a private room.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •Other exclusion criteria include those individuals who are prisoners.
结局指标
主要结局
MR Elastography Results Compared to Methacetin Breath Test Results in Patients Undergoing Heart and Liver Transplant Evaluation.
时间窗: 1 hour for MR elastography
To explore any association between MBT parameter and clinical parameters available. Liver stiffness (using ARFI or MR elastography).
Methacetin Breath Test Results in Patients Undergoing Heart and Liver Transplant Evaluation.
时间窗: 90 minutes MBT measurement is taken
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.
To Explore Any Association Between MBT Parameter and Clinical Parameters Already Available Per Standard of Care in Patients Undergoing Heart and Liver Transplant Evaluation.
时间窗: 1 year
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.
次要结局
未报告次要终点
研究者
Daniel Ganger
Principal Investigator
Northwestern University