Multiparametric Cardio-hepatic MRI in Patients With Noncirrhotic Portal Hypertension

Sponsor
University Hospital, Bonn (Other)
Overall Status
Recruiting
CT.gov ID
NCT05041452
Collaborator
(none)
60
2
32.1
30
0.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Multiparametric Cardio-hepatic MRI in Patients With Noncirrhotic Portal Hypertension
Actual Study Start Date :
Apr 29, 2021
Anticipated Primary Completion Date :
Apr 29, 2022
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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].

  2. 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 [%].

  3. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital Bonn, Clinic for Diagnostic and Interventional Radiology Bonn NRW Germany 53127
2 University Hospital Bonn, Medical Clinic and Polyclinic I Bonn NRW Germany 53127

Sponsors and Collaborators

  • University Hospital, Bonn

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Julian Alexander Luetkens, Principal Investigator, Senior Physician, University Hospital, Bonn
ClinicalTrials.gov Identifier:
NCT05041452
Other Study ID Numbers:
  • 282/18
First Posted:
Sep 13, 2021
Last Update Posted:
Sep 13, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Julian Alexander Luetkens, Principal Investigator, Senior Physician, University Hospital, Bonn
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 13, 2021