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Prognostic Value of Measuring DsAz by MRI in Cirrhotic Patients on Prophylactic Treatment With β Blocker (AzyMR) (AzyMR)

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ClinicalTrials.gov Identifier: NCT02475122
Recruitment Status : Unknown
Verified November 2014 by University Hospital, Angers.
Recruitment status was:  Recruiting
First Posted : June 18, 2015
Last Update Posted : June 18, 2015
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers

Brief Summary:

Portal hypertension (PHT) that leads to esophageal varices is clinically present, at the time of diagnosis, in 60% of cirrhotic patients (Groszmann NEJM 2005). Variceal bleeding is a life-threatening complication. The yearly incidence of the first variceal bleeding in cirrhotic patients is estimated to 4%. This risk increases to 15% when medium or large varices are initially present, (D'amico Baillieres Clin Gastroenterol 1997); Therefore, for patient with medium or large varices a primary prophylaxis treatment with nonselective beta-blockers must be instituted decreasing risk of bleeding approximately by half (d'amico Hepatology 2005).

The method to evaluate the efficacy of beta blockers treatment is the hepatic venous pressure gradient (HVPG). HVPG < 12 mmHg or a decrease of HVPG of 20% after beta blocker treatment reduce dramatically the risk of bleeding (Feu F. Lancet 1995). But a good response (HVPG < 12 mmHg or reduction > 20%) to beta blockers was observed only in almost 30 % of patients. In non responder patients, the variceal bleeding incidence is estimated to 24 % at 2 years.

In this situation, alternative treatments to beta-blockers have been suggested: endoscopic ligation, which was shown to be as effective as beta blockers in primary prevention, and more recently carvedilol (Reiberger, Gut 2012).

So, HVPG monitoring may provide critical information for patients. However, because of its technical requirement and its invasivity, HVPG measurement is not feasible in clinical practice . So, there is a general consensus to continue indefinitely beta blockers treatment without control of hemodynamic efficiency (merkel J. Hepatology 2009).

Previous studies have suggested the interest of azygos blood flow measurements for evaluating hemodynamic changes in the esophageal collateral vessels of patients with portal hypertension (Bosch J. Hepatology 1985 ). More recently Magnetic Resonance Imaging (MRI) has been reported to be an efficient technique to assess azygos blood flow (Gouya Radiology 2011) in cirrhotic patients. Its feasibility is obviously higher than HVPG measurement.

However, in the same way that HVPG, a large-scale implementation in clinical practice of azygos blood flow measurement by MRI requires to specify minimal absolute threshold, or relative post-therapeutic decrease, related with no variceal bleeding.


Condition or disease Intervention/treatment Phase
Bleeding Esophageal Varices Cirrhosis Other: azygos blood flow measurements by MRI Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Prognostic Value of Measuring DsAz by MRI in Cirrhotic Patients on Prophylactic Treatment With β Blocker (AzyMR)
Study Start Date : October 2014
Estimated Primary Completion Date : April 2016
Estimated Study Completion Date : April 2018


Arm Intervention/treatment
open-label study
open-label study
Other: azygos blood flow measurements by MRI



Primary Outcome Measures :
  1. Number an severity of adverse events occurring during follow up [ Time Frame: during 2 years ]


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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:

Cirrhotic patients requiring β blocker in primary prophylaxis of bleeding esophageal varices

Exclusion Criteria:

  • Patients under 18 year's old
  • life expectancy of less than one month
  • Patient already has a vasoactive treatment
  • patient with CHC or portal vein thrombosis
  • patient without social security or deprived of freedom
  • contraindication to MRI
  • contraindication to beta-blockers
  • mental state does not allow the signing of an informed consent

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): NCT02475122


Contacts
Contact: Antoine Bouvier, CCA AnBouvier@chu-angers.fr
Contact: Marie Bost, CRA MaBost@chu-angers.fr

Locations
France
CHU Angers Recruiting
Angers, France
Contact: Aubé Christophe       chaube@chu-angers.fr   
Principal Investigator: Aubé Christophe         
Sponsors and Collaborators
University Hospital, Angers

Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT02475122     History of Changes
Other Study ID Numbers: AOI 2014-02
First Posted: June 18, 2015    Key Record Dates
Last Update Posted: June 18, 2015
Last Verified: November 2014

Keywords provided by University Hospital, Angers:
Measurement of azygos blood flow

Additional relevant MeSH terms:
Esophageal and Gastric Varices
Gastrointestinal Hemorrhage
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Hypertension, Portal
Liver Diseases
Hemorrhage
Pathologic Processes
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs