Multiparametric Cardio-hepatic MRI in Patients With Noncirrhotic Portal Hypertension

Cardiomyopathies Clinical Trial

Official title:

Multiparametric Cardio-hepatic MRI in Patients With Noncirrhotic Portal Hypertension

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05041452
• Other study ID #: 282/18
• Status: Recruiting
• Start date: April 29, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: September 2021
• Source: University Hospital, Bonn
• Contact: Julian A Luetkens, PD Dr. med.
• Phone: +49 228 287-15960
• Email: julian.luetkens[@]ukbonn.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2023
• Est. primary completion date: April 29, 2022
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cardiomyopathies
• Hypertension
• Hypertension, Portal

Intervention

Diagnostic Test:
• Cardiac magnetic resonance scan
Multiparametric cardiac magnetic resonance, including functional and structural parameters

Locations

Country	Name	City	State
Germany	University Hospital Bonn, Clinic for Diagnostic and Interventional Radiology	Bonn	NRW
Germany	University Hospital Bonn, Medical Clinic and Polyclinic I	Bonn	NRW

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bonn

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.