NCT05749198

Brief Summary

This prospective study was conducted in a tertiary university hospital. The investigators researched the correlation between MRE-assessed stiffness of the liver and spleen and the Hepatic venous pressure gradient (HVPG) values. Furthermore, the investigator evaluated whether MRE-assessed stiffness reflected changes in portal hypertension (PH) after administering non-selective beta-blockers (NSBBs).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 2, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2023

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

February 14, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 1, 2023

Completed
Last Updated

March 1, 2023

Status Verified

February 1, 2023

Enrollment Period

1.7 years

First QC Date

February 14, 2023

Last Update Submit

February 28, 2023

Conditions

Portal HypertensionMagnetic Resonance Imaging

Outcome Measures

Primary Outcomes (2)

  • Change of liver stiffness and spleen stiffness by MRE

    Change from baseline stiffness of MRE at 6 months

  • The change of portal pressure (HVPG) prior to and after treatment with NSBB

    Change from baseline and at 6 months

Interventions

MREDIAGNOSTIC_TEST

MRE was performed using a 3T system (Magnetom Skyra; Siemens, Erlangen, Germany) equipped with a combination of a 30-channel body and a 32-channel spine matrix coil.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients requiring prophylactic treatment of esophageal varices

You may qualify if:

  • diagnosed liver cirrhosis
  • requiring prophylactic treatment of esophageal varices

You may not qualify if:

  • the coexistence of hepatocellular carcinoma
  • refractory ascites who regularly underwent large-volume paracentesis
  • the use of selective beta-blocker or carvedilol therapy for at least 4 weeks
  • undergoing liver transplantation
  • contraindication with magnetic resonance imaging

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, 22070, South Korea

Location

MeSH Terms

Conditions

Hypertension, Portal

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 14, 2023

First Posted

March 1, 2023

Study Start

January 2, 2018

Primary Completion

September 30, 2019

Study Completion

January 28, 2023

Last Updated

March 1, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)