Hypertension, PortalNCT05041452
Multiparametric Cardio-hepatic MRI in Patients With Noncirrhotic Portal Hypertension
An observational study of Hypertension, Portal and Cardiomyopathies, run by University Hospital, Bonn at 2 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hypertension, Portal, Cardiomyopathies
- What is being tested?
- Cardiac magnetic resonance scan
- How many people
- 60 participants
- Where
- 2 sitesGermany
- Study dates
- 29 Apr 2021to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Adult
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.
Who may be able to join
- noncirrhotic portal hypertension
- age at least 18 years
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
Germany2 sites, 2 recruiting
- Recruiting
University Hospital Bonn, Clinic for Diagnostic and Interventional Radiology
Bonn, North Rhine-Westphalia, 53127
Julian A Luetkens, PD Dr., julian.luetkens@ukbonn.de
Alexander Isaak, Dr., alexander.isaak@ukbonn.de
- Recruiting
University Hospital Bonn, Medical Clinic and Polyclinic I
Bonn, North Rhine-Westphalia, 53127
Michael Praktiknjo, Dr. med., +49 228 287-15770, michael.praktiknjo@ukbonn.de
Christian Jansen, Dr. med., +49 228 287-15770, christian.jansen@ukbonn.de
About this study
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.
Read the 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
- Being tested
- Cardiac magnetic resonance scan
- Keywords
- Cardiac MRI, Hepatic MRI
- Medical subject headings
- Hypertension, Portal, Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac magnetic resonance scanDiagnostic test
Multiparametric cardiac magnetic resonance, including functional and structural parameters
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Diagnostic Test: Cardiac magnetic resonance scan | |
| Cirrhotic portal hypertension | Patients with cirrhosis and portal hypertension. Receives: Diagnostic Test: Cardiac magnetic resonance scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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].
Measured: Measurement will be performed within 2 weeks after MRI scan.
Secondary outcomes (3)
Myocardial T2 relaxation time
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].
Measured: Measurement will be performed within 2 weeks after MRI scan.
Myocardial ECV
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 [%].
Measured: Measurement will be performed within 2 weeks after MRI scan.
Myocardial strain
Cardiac magnetic resonance feature-tracking will be used to asses left ventricular longitudinal, circumferential and radial strain.
Measured: Measurement will be performed within 2 weeks after MRI scan.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start29 Apr 2021
- Primary completion29 Apr 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension, PortalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julian Alexander Luetkens, University Hospital, Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05041452
- Sponsor's protocol ID
- 282/18
- Status last verified
- Sep 2021
- First submitted
- 27 Aug 2021
- Last updated
- 13 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiparametric Cardio-hepatic MRI in Patients With Noncirrhotic Portal Hypertension
- ClinicalTrials.gov ID
- NCT05041452
- Acronym / sponsor ID
- 282/18
- Conditions
- Hypertension, Portal, Cardiomyopathies
- Keywords
- Cardiac MRI, Hepatic MRI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Study start
- 29 Apr 2021 (actual)
- Primary completion
- 29 Apr 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 13 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Noncirrhotic portal hypertension (NCPH) | – | Diagnostic Test: Cardiac magnetic resonance scanPatients 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 | – | Diagnostic Test: Cardiac magnetic resonance scanPatients with cirrhosis and portal hypertension. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- noncirrhotic portal hypertension
- age at least 18 years
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac magnetic resonance scanMultiparametric cardiac magnetic resonance, including functional and structural parameters | Diagnostic test | Cirrhotic portal hypertension, Noncirrhotic portal hypertension (NCPH) |
Primary outcome
Myocardial T1 relaxation time
Time frame: 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].
3 secondary outcomes
Myocardial T2 relaxation time
Time frame: Measurement will be performed within 2 weeks after MRI scan.
Myocardial ECV
Time frame: Measurement will be performed within 2 weeks after MRI scan.
Myocardial strain
Time frame: Measurement will be performed within 2 weeks after MRI scan.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2021.
- Individual participant dataSharing planned: No
Related trials for Hypertension, Portal
RecruitingObservational study
The Value of Spleen Thickness and Spleen Diameter for Gastroesophageal Varices Diagnosis in Compensated Cirrhosis
Liver Cirrhosis, Gastroesophageal Varices
RecruitingObservational study
Treatment Outcomes and Predictors After Endovascular Intervention for Portal Hypertension-Related Gastrointestinal Bleeding in Cirrhosis
Cirrhosis, Portal Hypertension Related to Cirrhosis
Not yet recruitingObservational study
Development and Validation of a TIPS Prognostic Model
Portal Hypertension Related to Cirrhosis, Ascites
RecruitingObservational study
Natural History of Noncirrhotic Portal Hypertension
Cystic Fibrosis, Immunologic Deficiency Syndrome
RecruitingPhase 2
Perioperative Retlirafusp Alfa(Anti-PD-L1/TGF-β Bifunctional Fusion Protein) Plus Famitinib and GEMOX-Based Hepatic Arterial Infusion Chemotherapy for Locally Advanced Intrahepatic Cholangiocarcinoma: A Multicenter, Single-Arm, Exploratory Phase II Trial
Intrahepatic Cholangiocarcinoma (Icc), Neoadjuvant Therapy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, Portal and Cardiomyopathies, run by University Hospital, Bonn at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julian A Luetkens, PD Dr. med. (+49 228 287-15960, julian.luetkens@ukbonn.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial T1 relaxation time (time frame: Measurement will be performed within 2 weeks after MRI scan.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2021.