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Trial record 5 of 8 for:    PORTAL | Bern, Switzerland
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Assessing Portal Hypertension With Methacetin Breath Test

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ClinicalTrials.gov Identifier: NCT02143778
Recruitment Status : Completed
First Posted : May 21, 2014
Results First Posted : September 19, 2019
Last Update Posted : December 20, 2022
Sponsor:
Information provided by (Responsible Party):
Meridian Bioscience, Inc.

Study Description
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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,

Condition or disease Intervention/treatment Phase
Patients With Compensated Liver Cirrhosis Device: Methacetin Breath Test Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 246 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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
Actual Study Start Date : November 2014
Actual Primary Completion Date : December 2018
Actual Study Completion Date : January 2019

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Device: Methacetin Breath Test
13C labelled methacetin solution for breath test monitoring


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Hepatic Venous Pressure Gradient (HVPG)>=12; Severe Portal Hypertension (SPH) [ Time Frame: 1 hour ]
    Hepatic Venous Pressure Gradient greater than 12 (SPH) is an indicator of bleeding varices. 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 SPH and the agreement to the reference standard (HVPG) will be assessed in this study.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02143778


Locations
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United States, Connecticut
VA Connecticut HealthCare System
New Haven, Connecticut, United States, 06516
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
France
Hôpital Beaujon
Paris, France
Hopital Purpan
Toulouse, France
Spain
(University of Barcelona) Hospital Clinic
Barcelona, Spain
Hospital Universitario Ramón y Cajal
Madrid, Spain
Switzerland
Inselspital
Bern, Switzerland, 3010
Sponsors and Collaborators
Meridian Bioscience, Inc.
Investigators
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Principal Investigator: Juan Carlos Garcia Pagan, MD University Hospital Barcelona
  Study Documents (Full-Text)

Documents provided by Meridian Bioscience, Inc.:
Study Protocol and Statistical Analysis Plan  [PDF] November 21, 2016

More Information
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Responsible Party: Meridian Bioscience, Inc.
ClinicalTrials.gov Identifier: NCT02143778    
Other Study ID Numbers: CSPH-EX-4014
2014-002037-59 ( EudraCT Number )
First Posted: May 21, 2014    Key Record Dates
Results First Posted: September 19, 2019
Last Update Posted: December 20, 2022
Last Verified: December 2022
Keywords provided by Meridian Bioscience, Inc.:
MBT
CSPH
HVPG
Additional relevant MeSH terms:
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Liver Cirrhosis
Hypertension, Portal
Hypertension
Fibrosis
Vascular Diseases
 Cardiovascular Diseases
Pathologic Processes
Liver Diseases
Digestive System Diseases