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Assessing Portal Hypertension With Methacetin Breath Test | Clinical Trials | Clareo Health

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Assessing Portal Hypertension With Methacetin Breath Test

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

NCT02143778•Meridian Bioscience, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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 \>2.3.
•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
+11 more criteria

Locations (8)

VA Connecticut HealthCare System

New Haven, Connecticut, United States

Duke University Medical Center

Durham, North Carolina, United States

Virginia Commonwealth University

Richmond, Virginia, United States

Hôpital Beaujon

Paris, France

Hopital Purpan

Toulouse, France

(University of Barcelona) Hospital Clinic

Barcelona, Spain

Hospital Universitario Ramón y Cajal

Madrid, Spain

Inselspital

Bern, Switzerland

Key Dates

Start Date

November 1, 2014

Primary Completion Date

December 1, 2018

Completion Date

January 1, 2019

Last Updated

December 20, 2022

Enrollment

246

ACTUAL participants

Conditions

Patients With Compensated Liver Cirrhosis

Interventions

Methacetin Breath Test

DEVICE