MRI to Assess the Effect of Non-selective Beta-blocker in Patients With Cirrhosis
Condition: Portal Hypertension; Cirrhosis; Esophageal Varices; Gastric Varices Bleeding; Varice Bleed; Liver Diseases; Liver Cirrhosis
MeSH terms: Liver Diseases; Liver Cirrhosis; Hypertension, Portal; Esophageal and Gastric Varices; Varicose Veins; Fibrosis
Study type: Observational

Summary: 
      Background:

      Standardization and new therapeutic treatments of variceal bleeding has significantly reduced
      the mortality the last 25 years, but there is still a high 6-week mortality around 15-20% and
      1-year mortality of about 40%. Cirrhotic patients without prophylactic treatment suffer a
      risk of 60% of re-bleeding within the first year after the first bleeding episode. Variceal
      ligation and NSBB are the standard therapy as secondary prophylaxis, while only non-selective
      beta-blocker (NSBB) is offered as first-line therapy in primary prophylaxis. If portal
      pressure is reduced to a value below 12 mmHg or by 20% (10% if assessed by intravenous
      administrations), the risk of bleeding is substantially reduced, but not all patients respond
      to the treatment with propranolol (40-50%). Hence, patients who are non-responders to NSBB
      should be offered alternative treatment with e.g. carvedilol, which is a combined
      alpha-beta-receptor blocker or endoscopic band ligation. Currently, the response to NSBB is
      assessed invasively during a liver vein catheterization (LVC). Unfortunately, only a few
      centres in the world can perform this procedure and there are no reliable non-invasive
      alternatives to assess the respond to NSBB, which is of extreme importance, since
      non-responders have three fold increased risk of a new variceal bleeding episode.

      Aim:

      In general the aim of the project is to develop faster and non-invasive methods to evaluate
      portal hypertension and individual pharmacological response of NSBB in patients with
      cirrhosis. Furthermore, we expect to detect changes in liver and spleen stiffness as measured
      by MR-Elastography (MRE) after NSBB and that these depend on the drug-related effects on
      portal pressure.

      Study design and patients:

      39 patients with cirrhosis and esophageal varices that require NSBB (propranolol) treatment.

      Patients are assessed with LVC, MR-scans, echocardiography and biochemical tests. LVC is the
      gold standard method to test if patients respond to propranolol treatment. At visit 1. the
      response to NSBB is defined as a reduction of HVPG ≥10%, or to a HVPG< 12mmHg after
      intravenous NSBB administrations during LVC. MRI-scan with intraveneus NSBB administration is
      performed at visit 2. Minimum 5 days of NSBB wash out between visit 1 and 2.
    

Detailed description: 
      MR-elastography and Phase Contrast MRI compared to LVC
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        39 patients with cirrhosis and esophageal varices that require NSBB (propranolol)
        treatment.
      
Biospecimen description: 
      Standard clinical blood tests and pertinent bioactive substances is measured in blood and
      urine
    
Keywords: Non-selective beta-blocker; Pharmacological respons; Magnetic Resonance Imaging; Hemodynamic assessments; Echocardiography; MR-elastography; Propranolol; Liver vein catheterization