Hypertension, Portal
Conditions
Keywords
HVPG, portal hypertension, ARFI, portal vein flow, advanced liver chronic disease (ACLD)
Brief summary
This study evaluates correlation in changes of HVPG-pressure values and stiffness values (ARFI) for spleen and liver and flow-volume values in Portal vein in patients with liver cirrhosis/Portal Hypertension, respectively, after new-admission of beta-blocker therapy.
Detailed description
Portal Hypertension is the most important risk factor for development of liver cirrhosis-linked complications (e.g. ascites, variceal bleeding, hepatocellular carcinoma, etc.). The invasive HVPG-technique is the standard-of-care Investigation for Evaluation of Portal Hypertension. Administration of Beta-Blocker-therapy results in dropping of the elevated Portal vein pressure values so Overall-survival rate and incidence of liver-cirrhosis-linked complications can be ameliorated. Ultrasound-based Investigation of liver and Spleen-stiffness and of portal-vein-flow-volume, respectively, are the non-invasive methods for Evaluation of Portal Hypertension. But the cut-off values for detection of significant Portal Hypertension by the ultrasound investigation strongly vary depending on the study performed. This study evaluates the changes in ARFI-assisted elastography measurements of liver and spleen and in portal vein flow values, respectively, compared with the recorded Delta in invasive hepatic vein pressure gradient (HVPG)-values for patients with portal hypertension and new administered beta-blocker-therapy. The aim of this study is to evaluate value drop in liver- and Spleen-stiffness and portal-vein-flow required in corelation to a significant drop in HVPG-pressure after new-administered beta-blocker therapy.
Interventions
Liver and spleen-elastography assessed by ARFI-technique and the portal vein flow value-assessment by ultrasound investigation.
Evaluation of Portal Hypertension by HVPG-measurement
Sponsors
Study design
Eligibility
Inclusion criteria
* liver cirrhosis * portal hypertension * indication to beta-blocker-therapy
Exclusion criteria
* contraindication to beta-blocker-therapy * HVPG-measurement not feasible * portal vein thrombosis * hematologic underlying disease as the source for enlarged/stiff spleen or liver
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in ARFI-elastography value for spleen due to beta-blocker therapy | 6 and 12 weeks | ARFI-elastography: measured in m/s |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between changes in HVPG-values and ARFI-elastography values for liver | 6 and 12 weeks | HVPG-values: measured in mmHg; ARFI-elastography: measured in m/s |
| Correlation between changes in HVPG-values and ARFI-elastography values for spleen | 6 and 12 weeks | HVPG-values: measured in mmHg; ARFI-elastography: measured in m/s |
| Correlation between changes in HVPG-values and portal vein flow measurements | 6 and 12 weeks | HVPG-values: measured in mmHg; Portal vein flow: measured in cm/s |
| Correlation between changes in grade of esophageal varices and ARFI-values for liver | 12 weeks | esophageal varices: modified Poquet classification; ARFI-elastography: measured in m/s |
| Correlation between changes in grade of esophageal varices and HVPG-values | 12 weeks | esophageal varices: modified Poquet classification; HVPG-values: measured in mmHg |
| Correlation between changes in grade of esophageal varices and Portal vein flow | 12 weeks | Portal vein flow: measured in cm/s; esophageal varices: modified Poquet classification |
| Change in ARFI-elastography value for liver due to beta-blocker therapy | 6 and 12 weeks | ARFI-elastography: measured in m/s |
| Change in portal vein flow value due to beta-blocker therapy | 6 and 12 weeks | Portal vein flow: measured in cm/s |
| Correlation between changes in grade of esophageal varices and ARFI-values for spleen | 12 weeks | esophageal varices: modified Poquet classification; ARFI-elastography: measured in m/s |
Countries
Germany