Characterization of the Liver Parenchyma Using Parametric T1 and T2 Magnetic Resonance Relaxometry

NCT04623528 | Completed

• 1 other identifier: S64242
• Study Type: observational
• Target: 224
• Locations: 0 countries
• Sites: N/A

Brief Summary

• To determine normal T1 and T2 values of the liver, and to assess the impact of age and gender
• To determine the relation between markers of right heart decompensation and T1/T2 values of the liver in patients with pulmonary hypertension, patients with dilated cardiomyopathy, and patients with constrictive pericarditis (or constrictive physiology)
• To determine inter/intra-observer reproducibility for liver T1/T2 assessment
• To test/develop multi-feature texture analysis for T1/T2 analysis of the liver and implement machine learning to derive indicative features (MR-derived measures only vs combined with other clinical readouts)

Conditions

Cardiomyopathy, Congestive; Pulmonary Hypertension; Constrictive Pericarditis; Cardiomyopathy, Dilated

Keywords

Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

• Value of MR relaxometry to depict liver congestion

  Comparing T1, T2 values of the liver with established techniques to depict liver congestion, eg serum liver biomarkers, right atrial pressure measurement/estimation at cardiac catheterization/transthoracic echocardiography

  through study completion, an average of 1 year

Study Arms (6)

Pericarditis patients with constrictive physiology

Patients with pericarditis and signs of constrictive physiology (increased ventricular coupling)

Diagnostic Test: T1 and T2 relaxometry of the liver parenchyma

Pericarditis patients without constrictive physiology

Patients with pericarditis but without signs of constrictive physiology (normal ventricular coupling)

Diagnostic Test: T1 and T2 relaxometry of the liver parenchyma

Dilated cardiomyopathy patients with biventricular systolic dysfunction

Patients with nonischemic dilated cardiomyopathy and left ventricular and right ventricular ejection fraction less than 35%

Diagnostic Test: T1 and T2 relaxometry of the liver parenchyma

Dilated cardiomyopathy patients with preserved right ventricular systolic dysfunction

Patients with nonischemic dilated cardiomyopathy and left ventricular ejection fraction less than 35%, and right ventricular function \>45%

Diagnostic Test: T1 and T2 relaxometry of the liver parenchyma

Patients with pulmonary arterial hypertension

Cohort of patients with pulmonary hypertension, either idiopathic or secondary to pulmonary emboli

Diagnostic Test: T1 and T2 relaxometry of the liver parenchyma

Control group

Cohort of subjects with no evidence of pericarditis, pulmonary hypertension, dilated cardiomyopathy and normal findings at cardiovascular magnetic resonance imaging

Diagnostic Test: T1 and T2 relaxometry of the liver parenchyma

Interventions

T1 and T2 relaxometry of the liver parenchyma DIAGNOSTIC_TEST

Evaluate T1 and T2 relaxomatry of the liver parenchyma to depict liver congestion in the different patient groups

Control group; Dilated cardiomyopathy patients with biventricular systolic dysfunction; Dilated cardiomyopathy patients with preserved right ventricular systolic dysfunction; Patients with pulmonary arterial hypertension; Pericarditis patients with constrictive physiology; Pericarditis patients without constrictive physiology

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

* pericarditis patients, defined by current standard criteria, with and without increased ventricular coupling (using free breathing cine MRI) * dilated cardiomyopathy, defined by current standard criteria, based on left ventricular ejection fraction (i.e. 35%) and right ventricular ejection (i.e. \> 45% or \< 35%), defined as DCM without and with right ventricular (RV) dysfunction, respectively * pulmonary artery patients, defined by current standard criteria.

You may qualify if:

• based on current standard criteria for defining constrictive pericarditis, dilated cardiomyopathy and pulmonary hypertension

You may not qualify if:

• claustrophobia
• pregnancy
• contra-indications for MRI

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• King's College London: collaborator

MeSH Terms

Conditions

Cardiomyopathy, Dilated; Hypertension, Pulmonary; Pericarditis, Constrictive

Condition Hierarchy (Ancestors)

Cardiomegaly; Heart Diseases; Cardiovascular Diseases; Cardiomyopathies; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Pericarditis

Study Officials

• Jan Bogaert, MD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: November 10, 2020
• Study Start: January 1, 2014
• Primary Completion: January 1, 2020
• Study Completion: October 1, 2020
• Last Updated: November 10, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share