- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03315767
Spleen-ARFI-assisted-Portal-Hypertension-Evaluation-Study (SAPHES) (SAPHES)
Prospective Evaluation of Non-invasive ARFI-elastography of Liver and Spleen and Portal Flow Measurement in Comparison With Invasive HVPG (Hepatic Venous Pressure Gradient)-Measurement for Patients With Portal Hypertension.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Eugen Zizer, MD
- Phone Number: 0049-73150044751
- Email: eugen.zizer@uniklinik-ulm.de
Study Contact Backup
- Name: Mark Hänle
- Phone Number: 0049-7315000
- Email: mark.haenle@uniklinik-ulm.de
Study Locations
-
-
-
Ulm, Germany
- Recruiting
- Universitatsklinikum Ulm
-
Contact:
- Eugen Zizer, MD
- Phone Number: 0049-731-500-44751
- Email: eugen.zizer@uniklinik-ulm.de
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: cirrhosis patients
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. |
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in ARFI-elastography value for spleen due to beta-blocker therapy
Time Frame: 6 and 12 weeks
|
ARFI-elastography: measured in m/s
|
6 and 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation between changes in HVPG-values and ARFI-elastography values for liver
Time Frame: 6 and 12 weeks
|
HVPG-values: measured in mmHg; ARFI-elastography: measured in m/s
|
6 and 12 weeks
|
Correlation between changes in HVPG-values and ARFI-elastography values for spleen
Time Frame: 6 and 12 weeks
|
HVPG-values: measured in mmHg; ARFI-elastography: measured in m/s
|
6 and 12 weeks
|
Correlation between changes in HVPG-values and portal vein flow measurements
Time Frame: 6 and 12 weeks
|
HVPG-values: measured in mmHg; Portal vein flow: measured in cm/s
|
6 and 12 weeks
|
Correlation between changes in grade of esophageal varices and HVPG-values
Time Frame: 12 weeks
|
esophageal varices: modified Poquet classification; HVPG-values: measured in mmHg
|
12 weeks
|
Correlation between changes in grade of esophageal varices and ARFI-values for liver
Time Frame: 12 weeks
|
esophageal varices: modified Poquet classification; ARFI-elastography: measured in m/s
|
12 weeks
|
Correlation between changes in grade of esophageal varices and ARFI-values for spleen
Time Frame: 12 weeks
|
esophageal varices: modified Poquet classification; ARFI-elastography: measured in m/s
|
12 weeks
|
Correlation between changes in grade of esophageal varices and Portal vein flow
Time Frame: 12 weeks
|
Portal vein flow: measured in cm/s; esophageal varices: modified Poquet classification
|
12 weeks
|
Change in ARFI-elastography value for liver due to beta-blocker therapy
Time Frame: 6 and 12 weeks
|
ARFI-elastography: measured in m/s
|
6 and 12 weeks
|
Change in portal vein flow value due to beta-blocker therapy
Time Frame: 6 and 12 weeks
|
Portal vein flow: measured in cm/s
|
6 and 12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Eugen Zizer, MD, University of Ulm
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SAPHES
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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