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Clinical Trials/NCT05041452
NCT05041452
Unknown
Not Applicable

Multiparametric Cardio-hepatic MRI in Patients With Noncirrhotic Portal Hypertension

University Hospital, Bonn2 sites in 1 country60 target enrollmentApril 29, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypertension, Portal
Sponsor
University Hospital, Bonn
Enrollment
60
Locations
2
Primary Endpoint
Myocardial T1 relaxation time
Last Updated
4 years ago

Overview

Brief Summary

The aim of this study is to use multiparametric MRI to investigate any differences in myocardial structure and function in patients with noncirrhotic portal hypertension compared with a control group with liver cirrhosis.

Detailed Description

The term "cirrhotic cardiomyopathy" (CCM) was defined in 2005 according to expert consensus at the "World Congress of Gastroenterology" in Montreal as a clinical phenotype in patients with liver cirrhosis consisting of systolic and diastolic dysfunction and a complementary criterion, such as electrophysiological changes, without the presence of a known underlying cardiac disease. For a long time, CCM was considered to result from toxic effects of alcohol consumption. The current view is that CCM is a separate entity independent of the various etiologies of liver cirrhosis. Thus, generally impaired liver function and portal hypertension with splanchnic vasodilation leads to altered hemodynamic conditions with central hypovolemia, increased activation of volume and baroreceptors, especially of the sympathetic nervous system, resulting in a "hyperdynamic syndrome" with increased cardiac stress. However, the contribution of portal hypertension to CCM is unclear. With new MRI techniques such as cardiac T1 and T2 mapping and extracellular volume fraction (ECV), quantitative parameters are available to detect pathologies of the myocardium before they become detectable with conventional techniques in cardiac MRI or echocardiography. The aim of this study is to use multiparametric MRI to investigate any differences in myocardial structure and function in patients with noncirrhotic portal hypertension compared with a control group with liver cirrhosis and to investigate a quantifiable correlation between cardiac, hepatic, and splenic parameters.

Registry
clinicaltrials.gov
Start Date
April 29, 2021
End Date
December 31, 2023
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Bonn
Responsible Party
Principal Investigator
Principal Investigator

Julian Alexander Luetkens

Principal Investigator, Senior Physician

University Hospital, Bonn

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Myocardial T1 relaxation time

Time Frame: Measurement will be performed within 2 weeks after MRI scan.

T1 relaxation times will be obtained to asses acute myocardial injury and fibrosis. T1 maps will be analyzed using a segmental approach by region of interest analysis. T1 relaxation times are given in \[ms\].

Secondary Outcomes

  • Myocardial T2 relaxation time(Measurement will be performed within 2 weeks after MRI scan.)
  • Myocardial strain(Measurement will be performed within 2 weeks after MRI scan.)
  • Myocardial ECV(Measurement will be performed within 2 weeks after MRI scan.)

Study Sites (2)

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