Assessing Portal Hypertension With Methacetin Breath Test

NCT ID: NCT02143778

Last Updated: 2022-12-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 246 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2019-01-31

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.

Conditions

Patients With Compensated Liver Cirrhosis

Keywords

MBT; CSPH; HVPG

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Compensated cirrhotic patients

A methacetin breath test will be performed on patients who are undergoing the HVPG procedure due to their clinical indication of compensated cirrhosis.

Group Type: EXPERIMENTAL

Methacetin Breath Test

Intervention Type: DEVICE

13C labelled methacetin solution for breath test monitoring

Interventions

Methacetin Breath Test

13C labelled methacetin solution for breath test monitoring

Intervention Type: DEVICE

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 >2.3.
• 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
• Total parenteral nutrition
• Any organ transplant recipient
• Pregnant or breast feeding
• Allergy to acetaminophen and/or other related medications
• Documented drug-related concurrent hepatotoxicity or drug-related silent steatosis or drug-related fibrosis (e.g. amiodarone, methotrexate and tamoxifen)
• Uncontrolled malabsorption or diarrhea
• Documented non-cirrhotic PHT, partial / complete portal venous occlusion, hepatic venous occlusion, previous PHT surgery, or placement of a transjugular intrahepatic portosystemic shunt (TIPS)
• Primary or secondary biliary cirrhosis, primary or secondary sclerosing cholangitis, hepatic sarcoidosis, or other cholestatic disorders
• Subjects unable to perform the MBT within 7 days of HVPG procedure.
• Subject should not have taken any of the following for at least 48 hours prior to the breath test: Acyclovir , allopurinol, amiodarone, carbamazepine, cimetidine, ciprofloxacin, daidzein, (herbal) disulfiram, echinacea, enoxacin, famotidine, fluvoxamine, methoxsalen, mexiletine, montelukast, norfloxacin, phenylpropanolamine, phenytoin, propafenone, rifampin, terbinafine, ticlopidine, thiabendazole, verapamil, zileuton or oral contraceptives or any medication that might interfere with Methacetin metabolism or might affect CYP 1A2
• Subject should not have taken amiodarone or statins within the last 30 days prior to the breath test or HVPG procedure

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Meridian Bioscience, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Juan Carlos Garcia Pagan, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Barcelona

Locations

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

Countries

United States; France; Spain; Switzerland

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2014-002037-59

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CSPH-EX-4014

Identifier Type: -

Identifier Source: org_study_id