NCT03315767

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 16, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 20, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

October 20, 2017

Status Verified

October 1, 2017

Enrollment Period

1.6 years

First QC Date

October 16, 2017

Last Update Submit

October 16, 2017

Conditions

Hypertension, Portal

Keywords

HVPGportal hypertensionARFIportal vein flowadvanced liver chronic disease (ACLD)

Outcome Measures

Primary Outcomes (1)

  • Change in ARFI-elastography value for spleen due to beta-blocker therapy

    ARFI-elastography: measured in m/s

    6 and 12 weeks

Secondary Outcomes (9)

  • Correlation between changes in HVPG-values and ARFI-elastography values for liver

    6 and 12 weeks

  • Correlation between changes in HVPG-values and ARFI-elastography values for spleen

    6 and 12 weeks

  • Correlation between changes in HVPG-values and portal vein flow measurements

    6 and 12 weeks

  • Correlation between changes in grade of esophageal varices and HVPG-values

    12 weeks

  • Correlation between changes in grade of esophageal varices and ARFI-values for liver

    12 weeks

  • +4 more secondary outcomes

Study Arms (1)

cirrhosis patients

OTHER

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 measurementDiagnostic Test: HVPG-measurement

Interventions

ARFI-elastography and portal vein flow measurementDIAGNOSTIC_TEST

Liver and spleen-elastography assessed by ARFI-technique and the portal vein flow value-assessment by ultrasound investigation.

cirrhosis patients
HVPG-measurementDIAGNOSTIC_TEST

Evaluation of Portal Hypertension by HVPG-measurement

cirrhosis patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • liver cirrhosis
  • portal hypertension
  • indication to beta-blocker-therapy

You may not qualify if:

  • contraindication to beta-blocker-therapy
  • HVPG-measurement not feasible
  • portal vein thrombosis
  • hematologic underlying disease as the source for enlarged/stiff spleen or liver

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsklinikum Ulm

Ulm, Germany

RECRUITING

Related Publications (1)

  • Binzberger A, Hanle M, Pfahler M, Kratzer W, Seufferlein T, Zizer E. Spleen and Liver Stiffness Evaluation by ARFI Imaging: A Reliable Tool for a Short-Term Monitoring of Portal Hypertension? Int J Hepatol. 2022 Sep 9;2022:7384144. doi: 10.1155/2022/7384144. eCollection 2022.

    PMID: 36117519DERIVED

MeSH Terms

Conditions

Hypertension, Portal

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System Diseases

Study Officials

  • Eugen Zizer, MD

    University of Ulm

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eugen Zizer, MD

CONTACT

0049-73150044751eugen.zizer@uniklinik-ulm.de

Mark Hänle

CONTACT

0049-7315000mark.haenle@uniklinik-ulm.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department Internal Medicine I

Study Record Dates

First Submitted

October 16, 2017

First Posted

October 20, 2017

Study Start

January 10, 2017

Primary Completion

August 1, 2018

Study Completion

December 1, 2018

Last Updated

October 20, 2017

Record last verified: 2017-10

Locations

DE(1)