Multiparametric Cardio-hepatic MRI in Patients With Noncirrhotic Portal Hypertension

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiomyopathies; Hypertension, Portal
• Intervention / Treatment: Diagnostic test: Cardiac magnetic resonance scan

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 Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Alexander Isaak, Dr. med.; Phone Number: +49 228 287-15960; Email: alexander.isaak@ukbonn.de

Study Locations

• Germany
  • NRW
    • Bonn, NRW, Germany, 53127
      • Recruiting
      • University Hospital Bonn, Clinic for Diagnostic and Interventional Radiology
    • Bonn, NRW, Germany, 53127
      • Recruiting
      • University Hospital Bonn, Medical Clinic and Polyclinic I
      • Contact: Michael Praktiknjo, Dr. med.; Phone Number: +49 228 287-15770; Email: michael.praktiknjo@ukbonn.de
      • Contact: Christian Jansen, Dr. med.; Phone Number: +49 228 287-15770; Email: christian.jansen@ukbonn.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with clinically diagnosed noncirrhotic portal hypertension who are being treated at the Medical Clinic and Polyclinic I of the University Hospital Bonn are included.

Description

Inclusion criteria:

1. noncirrhotic portal hypertension
2. age at least 18 years

Exclusion criteria:

1. underlying cardiac disease, e.g., coronary heart disease/myocardial infarction, myocarditis, cardiomyopathies of other causes, congenital heart disease
2. patients who are using a intrauterinpessare for contraception
3. pregnant and breastfeeding women
4. patients with contraindications for MRI (not suitebale metallic implants)
5. patients with contraindications for MRI contrast agents (renal insufficiency, allergy)

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Noncirrhotic portal hypertension (NCPH); 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).	Diagnostic test: Cardiac magnetic resonance scan; Multiparametric cardiac magnetic resonance, including functional and structural parameters
Cirrhotic portal hypertension; Patients with cirrhosis and portal hypertension.	Diagnostic test: Cardiac magnetic resonance scan; Multiparametric cardiac magnetic resonance, including functional and structural parameters

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Myocardial T1 relaxation time	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].	Measurement will be performed within 2 weeks after MRI scan.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Myocardial T2 relaxation time	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].	Measurement will be performed within 2 weeks after MRI scan.
Myocardial ECV	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 [%].	Measurement will be performed within 2 weeks after MRI scan.
Myocardial strain	Cardiac magnetic resonance feature-tracking will be used to asses left ventricular longitudinal, circumferential and radial strain.	Measurement will be performed within 2 weeks after MRI scan.

Collaborators and Investigators

• Sponsor: University Hospital, Bonn

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2021
• Primary Completion (Anticipated): April 29, 2022
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: August 27, 2021
• First Submitted That Met QC Criteria: September 2, 2021
• First Posted (Actual): September 13, 2021

Study Record Updates

• Last Update Posted (Actual): September 13, 2021
• Last Update Submitted That Met QC Criteria: September 2, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Cardiac MRI; Hepatic MRI
• Additional Relevant MeSH Terms: Digestive System Diseases; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Liver Diseases; Hypertension; Cardiomyopathies; Hypertension, Portal
• Other Study ID Numbers: 282/18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No