Multiparametric Cardio-hepatic MRI in Patients With Noncirrhotic Portal Hypertension
1 other identifier
observational
60
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2021
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 29, 2021
CompletedFirst Submitted
Initial submission to the registry
August 27, 2021
CompletedFirst Posted
Study publicly available on registry
September 13, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 29, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedSeptember 13, 2021
September 1, 2021
1 year
August 27, 2021
September 2, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Myocardial T2 relaxation time
Measurement will be performed within 2 weeks after MRI scan.
Myocardial ECV
Measurement will be performed within 2 weeks after MRI scan.
Myocardial strain
Measurement will be performed within 2 weeks after MRI scan.
Study Arms (2)
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).
Cirrhotic portal hypertension
Patients with cirrhosis and portal hypertension.
Interventions
Multiparametric cardiac magnetic resonance, including functional and structural parameters
Eligibility Criteria
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.
You may qualify if:
- noncirrhotic portal hypertension
- age at least 18 years
You may not qualify if:
- underlying cardiac disease, e.g., coronary heart disease/myocardial infarction, myocarditis, cardiomyopathies of other causes, congenital heart disease
- patients who are using a intrauterinpessare for contraception
- pregnant and breastfeeding women
- patients with contraindications for MRI (not suitebale metallic implants)
- patients with contraindications for MRI contrast agents (renal insufficiency, allergy)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University Hospital Bonn, Clinic for Diagnostic and Interventional Radiology
Bonn, North Rhine-Westphalia, 53127, Germany
University Hospital Bonn, Medical Clinic and Polyclinic I
Bonn, North Rhine-Westphalia, 53127, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator, Senior Physician
Study Record Dates
First Submitted
August 27, 2021
First Posted
September 13, 2021
Study Start
April 29, 2021
Primary Completion
April 29, 2022
Study Completion
December 31, 2023
Last Updated
September 13, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share