An interventional study of ARFI-elastography and portal vein flow measurement and HVPG-measurement in Hypertension, Portal, sponsored by University of Ulm. Status unknown at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-10-20.
Sponsored by University of Ulm · Not applicable, Interventional, and Diagnostic
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.
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.
Exclusion Criteria:
ARFI-elastography and portal vein flow measurement: Liver and spleen of patients with a scheduled HVPG-investigation will be examined by an ARFI-elastography-investigation. Additionally the portal vein flow will be assessed. This examination will be done at d0 before the start of beta-blocker-administration and repeated as monitoring for portal hypertension treated by beta-blocker after 6 and 12 weeks, respectively. HVPG-measurement: HVPG-values will be assessed at d0, after 6 and after 12 Weeks, respectively.
Diagnostic Test: ARFI-elastography and portal vein flow measurement · Diagnostic Test: HVPG-measurement
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
Change in ARFI-elastography value for spleen due to beta-blocker therapy
ARFI-elastography: measured in m/s
Time frame: 6 and 12 weeks
Correlation between changes in HVPG-values and ARFI-elastography values for liver
HVPG-values: measured in mmHg; ARFI-elastography: measured in m/s
Time frame: 6 and 12 weeks
Correlation between changes in HVPG-values and ARFI-elastography values for spleen
HVPG-values: measured in mmHg; ARFI-elastography: measured in m/s
Time frame: 6 and 12 weeks
Correlation between changes in HVPG-values and portal vein flow measurements
HVPG-values: measured in mmHg; Portal vein flow: measured in cm/s
Time frame: 6 and 12 weeks
Correlation between changes in grade of esophageal varices and HVPG-values
esophageal varices: modified Poquet classification; HVPG-values: measured in mmHg
Time frame: 12 weeks
Correlation between changes in grade of esophageal varices and ARFI-values for liver
esophageal varices: modified Poquet classification; ARFI-elastography: measured in m/s
Time frame: 12 weeks
Correlation between changes in grade of esophageal varices and ARFI-values for spleen
esophageal varices: modified Poquet classification; ARFI-elastography: measured in m/s
Time frame: 12 weeks
Correlation between changes in grade of esophageal varices and Portal vein flow
Portal vein flow: measured in cm/s; esophageal varices: modified Poquet classification
Time frame: 12 weeks
Change in ARFI-elastography value for liver due to beta-blocker therapy
ARFI-elastography: measured in m/s
Time frame: 6 and 12 weeks
Change in portal vein flow value due to beta-blocker therapy
Portal vein flow: measured in cm/s
Time frame: 6 and 12 weeks
Plan to share: Undecided
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University of Ulm