Multiparametric Cardio-hepatic MRI in Patients With Noncirrhotic Portal Hypertension

NCT ID: NCT05041452

Last Updated: 2021-09-13

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-04-29
• Study Completion Date: 2023-12-31

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.

Conditions

Hypertension, Portal; Cardiomyopathies

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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).

Cardiac magnetic resonance scan

Intervention Type: DIAGNOSTIC_TEST

Multiparametric cardiac magnetic resonance, including functional and structural parameters

Cirrhotic portal hypertension

Patients with cirrhosis and portal hypertension.

Cardiac magnetic resonance scan

Intervention Type: DIAGNOSTIC_TEST

Multiparametric cardiac magnetic resonance, including functional and structural parameters

Interventions

Cardiac magnetic resonance scan

Multiparametric cardiac magnetic resonance, including functional and structural parameters

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Bonn

OTHER

Sponsor Role: lead

Responsible Party

Julian Alexander Luetkens

Principal Investigator, Senior Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Hospital Bonn, Clinic for Diagnostic and Interventional Radiology

Bonn, North Rhine-Westphalia, Germany

Site Status: RECRUITING

University Hospital Bonn, Medical Clinic and Polyclinic I

Bonn, North Rhine-Westphalia, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Julian A Luetkens, PD Dr. med.

Role: CONTACT

julian.luetkens@ukbonn.de

+49 228 287-15960

Alexander Isaak, Dr. med.

Role: CONTACT

alexander.isaak@ukbonn.de

+49 228 287-15960

Facility Contacts

Julian A Luetkens, PD Dr.

Role: primary

julian.luetkens@ukbonn.de

Alexander Isaak, Dr.

Role: backup

alexander.isaak@ukbonn.de

Michael Praktiknjo, Dr. med.

Role: primary

michael.praktiknjo@ukbonn.de

+49 228 287-15770

Christian Jansen, Dr. med.

Role: backup

christian.jansen@ukbonn.de

+49 228 287-15770

Other Identifiers

282/18

Identifier Type: -

Identifier Source: org_study_id