Clinical trial NCT05041452: Multiparametric Cardio-hepatic MRI in Patients With Noncirrhotic Portal Hypertension
Official title: Multiparametric Cardio-hepatic MRI in Patients With Noncirrhotic Portal Hypertension
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypertension, Portal
Cardiomyopathies
Keywords: Cardiac MRI
Hepatic MRI
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
First posted: 2021-09-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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)

Primary outcomes:
measure: Myocardial T1 relaxation time
timeFrame: Measurement will be performed within 2 weeks after MRI scan.
Secondary outcomes:
measure: Myocardial T2 relaxation time
timeFrame: Measurement will be performed within 2 weeks after MRI scan.
measure: Myocardial ECV
timeFrame: Measurement will be performed within 2 weeks after MRI scan.
measure: Myocardial strain
timeFrame: Measurement will be performed within 2 weeks after MRI scan.
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: University Hospital Bonn, Clinic for Diagnostic and Interventional Radiology
state: NRW
city: Bonn
country: Germany
facility: University Hospital Bonn, Medical Clinic and Polyclinic I
state: NRW
Study officials:
References: