Portal Hypertension Using Magnetic Resonance Elastography

• Sponsor: Yonsei University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05749198
• Collaborator: (none)
• Enrollment: 47
• Location: 1
• Actual Duration (Months): 60.8
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Portal Hypertension; Magnetic Resonance Imaging	Diagnostic Test: MRE

Study Design

• Study Type: Observational
• Actual Enrollment: 47 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Non-invasive Assessment of Portal Hypertension Using Quantitative Magnetic Resonance Imaging
• Actual Study Start Date: Jan 2, 2018
• Actual Primary Completion Date: Sep 30, 2019
• Actual Study Completion Date: Jan 28, 2023

Outcome Measures

Primary Outcome Measures

1. Change of liver stiffness and spleen stiffness by MRE [Change from baseline stiffness of MRE at 6 months]

2. The change of portal pressure (HVPG) prior to and after treatment with NSBB [Change from baseline and at 6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• diagnosed liver cirrhosis

• requiring prophylactic treatment of esophageal varices

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wonju Severance Christian Hospital	Wŏnju	Gangwon	Korea, Republic of	22070

Sponsors and Collaborators

• Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Moon Young Kim, Professor, Yonsei University
• ClinicalTrials.gov Identifier: NCT05749198
• Other Study ID Numbers: CR317132
• First Posted: Mar 1, 2023
• Last Update Posted: Mar 1, 2023
• Last Verified: Feb 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hypertension, Portal; Hypertension

Study Results

No Results Posted as of Mar 1, 2023