MRI to Assess the Effect of Non-selective Beta-blocker in Patients With Cirrhosis
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|ClinicalTrials.gov Identifier: NCT03438916|
Recruitment Status : Recruiting
First Posted : February 20, 2018
Last Update Posted : August 7, 2019
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.
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.
|Condition or disease|
|Portal Hypertension Cirrhosis Esophageal Varices Gastric Varices Bleeding Varice Bleed Liver Diseases Liver Cirrhosis|
|Study Type :||Observational|
|Estimated Enrollment :||39 participants|
|Official Title:||Hemodynamic Alterations in Liver Cirrhosis Validated by Non-invasive MRI Compared to Invasive Assessment: Can MRI and Echocardiography Predict the Pharmacological Response of Non-selective Beta-blocker in Patients With Cirrhosis?|
|Actual Study Start Date :||April 1, 2017|
|Estimated Primary Completion Date :||April 2023|
|Estimated Study Completion Date :||April 2023|
- NSBB response defined as a reduction in HVPG >10% or HVPG <12 mmHG after intraveneus NSBB administrations compared to flow (mL/min) in splanchnic vessels [ Time Frame: after 20 minutes respons time ]To assess if changes in MR flow induced with NSBB (propranolol) administrations can predict the changes in HVPG after NSBB administration (NSBB respons) assessed by LVC
- MR-elastography [ Time Frame: after 20 minutes ]To assess the liver and spleen stiffness (kPa) with MRE before and after intraveneus NSBB administration
Biospecimen Retention: Samples Without DNA
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): NCT03438916
|Contact: Karen V Danielsen||+45 firstname.lastname@example.org|
|Contact: Flemming Bendtsen, Professoremail@example.com|
|Centre of Gastroenterology, Dept. of medicine. Hvidovre University Hospital||Recruiting|
|Hvidovre, Denmark, 2650|
|Contact: Flemming Bendtsen, Professor firstname.lastname@example.org|
|Principal Investigator:||Flemming Bendtsen, Professor||Professor|