Multiparametric Cardio-hepatic MRI in Patients With Noncirrhotic Portal Hypertension

• Conditions: Hypertension, Portal; Cardiomyopathies
• Interventions: Diagnostic Test: Cardiac magnetic resonance scan

• Registration Number: NCT05041452
• Lead Sponsor: University Hospital, Bonn

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.

Study Timeline

• Study Start: 2021-04-29
• Study First Submitted: 2021-08-27
• Status Verified: 2021-09
• Study First Submitted QC: 2021-09-02
• Last Update Submitted: 2021-09-02
• Study First Posted: 2021-09-13
• Last Update Posted: 2021-09-13
• Primary Completion: 2022-04-29
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cirrhotic portal hypertension	Cardiac magnetic resonance scan	Patients with cirrhosis and portal hypertension.
Noncirrhotic portal hypertension (NCPH)	Cardiac magnetic resonance scan	Patients with non-cirrhotic portal hypertension (NCPH) with pre-sinusoidal (e.g., porto-sinusoidal vascular disease, portal vein obstruction, congenital hepatic fibrosis, biliary diseases,), sinusoidal (e.g., sinusoidal destruction in the setting of acute hepatic injury, inflammatory or toxic fibrosis, non-alcoholic steatohepatitis), or post-sinusoidal causes (Budd-Chiari syndrome, sinusoidal obstruction syndrome).

Primary Outcome Measures

Name	Time	Method
Myocardial T1 relaxation time	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 Outcome Measures

Name	Time	Method
Myocardial T2 relaxation time	Measurement will be performed within 2 weeks after MRI scan.	T2 relaxation times will be obtained to asses myocardial edema. T2 maps will be analyzed using a segmental approach by region of interest analysis. T2 relaxation times are given in \[ms\].
Myocardial strain	Measurement will be performed within 2 weeks after MRI scan.	Cardiac magnetic resonance feature-tracking will be used to asses left ventricular longitudinal, circumferential and radial strain.
Myocardial ECV	Measurement will be performed within 2 weeks after MRI scan.	Myocardial extracellular volume will be obtained to asses extracellular space/myocardial fibrosis. ECV values will be calculated using a segmental approach by region of interest analysis of native and contrast-enhanced T1 relaxation maps. ECV values are given in \[%\].

Trial Locations

Locations (2)

University Hospital Bonn, Medical Clinic and Polyclinic I; 🇩🇪 Bonn, NRW, Germany

University Hospital Bonn, Clinic for Diagnostic and Interventional Radiology; 🇩🇪 Bonn, NRW, Germany