Clinical Study of the BreathID® LF System to Train the Algorithm for the ¹³C-Methacetin Breath Test (MBT) in Assessment of Portal Hypertension in Patients With Compensated Liver Cirrhosis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Patients With Compensated Liver Cirrhosis
- Sponsor
- Meridian Bioscience, Inc.
- Enrollment
- 246
- Locations
- 8
- Primary Endpoint
- CSPH (Clinically Significant Portal Hypertension)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
This study will be used to train an algorithm using Methacetin breath test (MBT) measures and to select a cut-off to determine presence or absence of Clinically Significant Portal Hypertension (CSPH) as defined by Hepatic Venous Gradient Pressure (HVPG) ≥ 10mmHg,
Detailed Description
The portal pressure leaving the liver is measured by using a balloon catheter before and after a wedge. The difference of the pressure between the wedge and the free is the hepatic venous pressure gradient. Methacetin breath test is hypothesized to also identify CSPH and the agreement to the reference standard (HVPG) will be assessed in this study.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adult men or women (\>18 years of age)
- •Known chronic liver disease with cirrhosis
- •Europe: Indicated to undergo HVPG testing
- •US: Consented for HVPG
- •For patients treated with beta blockers: They have to be on a stable dose for at least 6 weeks prior to any study related tasks
- •For patients who stopped their treatment with beta blockers: Their last dose should be at least 6 weeks prior to any study related tasks
Exclusion Criteria
- •Decompensated cirrhosis as clinically defined by the presence of ascites, hepatic encephalopathy, variceal bleeding or hepatorenal syndrome
- •Renal failure (creatinine \> 2.5 mg/dl)
- •Known acute renal tubular disease Known hypotension (Systolic Pressure \<100mmHg)
- •Hypocoagulablity defined as PT \>6 and INR \>2.
- •Congestive heart failure (assessed clinically as NIHA \>2)
- •Known pulmonary hypertension (right ventricular systolic pressure \> 45 mm Hg)
- •Uncontrolled diabetes mellitus (HBA1C \>9.5gr%)
- •Concurrent prednisone or immunosuppressive treatment, if therapy and/or response to treatment are not stable for at least 3 months.
- •Documented or suspected hepatocellular carcinoma
- •Gastric bypass surgery or extensive small bowel resection
Outcomes
Primary Outcomes
CSPH (Clinically Significant Portal Hypertension)
Time Frame: 1 hour
Clinically significant portal hypertension is defined as Hepatic Venous Pressure Gradient (HVPG)\>=10mmHg, whereby the portal pressure leaving the liver is measured by using a balloon catheter before and after a wedge. The difference of the pressure between the wedge and the free is the hepatic venous pressure gradient. Methacetin breath test is hypothesized to also identify CSPH and the agreement to the reference standard (HVPG) will be assessed in this study.
Secondary Outcomes
- Hepatic Venous Pressure Gradient (HVPG)>=12; Severe Portal Hypertension (SPH)(1 hour)