Hypertension, PortalSAPHESNCT03315767
Spleen-ARFI-assisted-Portal-Hypertension-Evaluation-Study (SAPHES)
A study testing ARFI-elastography and portal vein flow measurement and HVPG-measurement in people with Hypertension, Portal, run by University of Ulm at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Portal
- What is being tested?
- ARFI-elastography and portal vein flow measurement and HVPG-measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteGermany
- Study dates
- 10 Jan 2017to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- liver cirrhosis
- portal hypertension
- indication to beta-blocker-therapy
Who cannot join
- contraindication to beta-blocker-therapy
- HVPG-measurement not feasible
- portal vein thrombosis
- hematologic underlying disease as the source for enlarged/stiff spleen or liver
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Universitätsklinikum Ulm
Ulm
Eugen Zizer, MD, 0049-731-500-44751, eugen.zizer@uniklinik-ulm.de
About this study
Official title: 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.
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.
Read the 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.
- Conditions
- Hypertension, Portal
- Being tested
- ARFI-elastography and portal vein flow measurement, HVPG-measurement
- Keywords
- HVPG, portal hypertension, ARFI, portal vein flow, advanced liver chronic disease (ACLD)
- Medical subject headings
- Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
HVPG-measurementDiagnostic test
Evaluation of Portal Hypertension by HVPG-measurement
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: ARFI-elastography and portal vein flow measurement; Diagnostic Test: HVPG-measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ARFI-elastography value for spleen due to beta-blocker therapy
ARFI-elastography: measured in m/s
Measured: 6 and 12 weeks
Secondary outcomes (9)
Correlation between changes in HVPG-values and ARFI-elastography values for liver
HVPG-values: measured in mmHg; ARFI-elastography: measured in m/s
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 12 weeks
Change in ARFI-elastography value for liver due to beta-blocker therapy
ARFI-elastography: measured in m/s
Measured: 6 and 12 weeks
Change in portal vein flow value due to beta-blocker therapy
Portal vein flow: measured in cm/s
Measured: 6 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2017
- Study start10 Jan 2017
- Primary completionAug 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypertension, PortalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Seufferlein, University of Ulm
- Investigators
- Eugen Zizer, MD, Principal investigator, University of Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03315767
- Sponsor's protocol ID
- SAPHES
- Acronym
- SAPHES
- Status last verified
- Oct 2017
- First submitted
- 16 Oct 2017
- Last updated
- 20 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36117519
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT03315767
- Acronym / sponsor ID
- SAPHES / SAPHES
- Conditions
- Hypertension, Portal
- Keywords
- HVPG, portal hypertension, ARFI, portal vein flow, advanced liver chronic disease (ACLD)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of UlmUniversity, hospital or other
- Study start
- 10 Jan 2017 (actual)
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 20 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cirrhosis patients | Other | Diagnostic Test: ARFI-elastography and portal vein flow measurement, Diagnostic Test: HVPG-measurementARFI-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- liver cirrhosis
- portal hypertension
- indication to beta-blocker-therapy
Key exclusion criteria (4 listed)
- contraindication to beta-blocker-therapy
- HVPG-measurement not feasible
- portal vein thrombosis
- hematologic underlying disease as the source for enlarged/stiff spleen or liver
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARFI-elastography and portal vein flow measurementLiver and spleen-elastography assessed by ARFI-technique and the portal vein flow value-assessment by ultrasound investigation. | Diagnostic test | cirrhosis patients |
| HVPG-measurementEvaluation of Portal Hypertension by HVPG-measurement | Diagnostic test | cirrhosis patients |
Primary outcome
Change in ARFI-elastography value for spleen due to beta-blocker therapy
Time frame: 6 and 12 weeks
ARFI-elastography: measured in m/s
9 secondary outcomes
Correlation between changes in HVPG-values and ARFI-elastography values for liver
Time frame: 6 and 12 weeks
Correlation between changes in HVPG-values and ARFI-elastography values for spleen
Time frame: 6 and 12 weeks
Correlation between changes in HVPG-values and portal vein flow measurements
Time frame: 6 and 12 weeks
Correlation between changes in grade of esophageal varices and HVPG-values
Time frame: 12 weeks
Correlation between changes in grade of esophageal varices and ARFI-values for liver
Time frame: 12 weeks
Correlation between changes in grade of esophageal varices and ARFI-values for spleen
Time frame: 12 weeks
Correlation between changes in grade of esophageal varices and Portal vein flow
Time frame: 12 weeks
Change in ARFI-elastography value for liver due to beta-blocker therapy
Time frame: 6 and 12 weeks
Change in portal vein flow value due to beta-blocker therapy
Time frame: 6 and 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2017.
- Derived from this study: PubMed 36117519Binzberger 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eugen Zizer, MD principal investigator
University of Ulm
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ARFI-elastography and portal vein flow measurement and HVPG-measurement in people with Hypertension, Portal, run by University of Ulm at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eugen Zizer, MD (0049-73150044751, eugen.zizer@uniklinik-ulm.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ARFI-elastography value for spleen due to beta-blocker therapy (time frame: 6 and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03315767, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2017.