An observational study in Portal Hypertension, Cirrhosis and Esophageal Varices, sponsored by Hvidovre University Hospital. Completed at 1 site in Denmark. Open to participants aged 18 Years to 78 Years. Per ClinicalTrials.gov, last updated 2023-03-14.
Sponsored by Hvidovre University Hospital · Observational
Background:
Standardization and new therapeutic treatments of variceal bleeding has significantly reduced the mortality the last 25 years, but there is still a high 6-week mortality around 15-20% and 1-year mortality of about 40%. Cirrhotic patients without prophylactic treatment suffer a risk of 60% of re-bleeding within the first year after the first bleeding episode. Variceal ligation and NSBB are the standard therapy as secondary prophylaxis, while only non-selective beta-blocker (NSBB) is offered as first-line therapy in primary prophylaxis. If portal pressure is reduced to a value below 12 mmHg or by 20% (10% if assessed by intravenous administrations), the risk of bleeding is substantially reduced, but not all patients respond to the treatment with propranolol (40-50%). Hence, patients who are non-responders to NSBB should be offered alternative treatment with e.g. carvedilol, which is a combined alpha-beta-receptor blocker or endoscopic band ligation. Currently, the response to NSBB is assessed invasively during a liver vein catheterization (LVC). Unfortunately, only a few centres in the world can perform this procedure and there are no reliable non-invasive alternatives to assess the respond to NSBB, which is of extreme importance, since non-responders have three fold increased risk of a new variceal bleeding episode.
Aim:
In general the aim of the project is to develop faster and non-invasive methods to evaluate portal hypertension and individual pharmacological response of NSBB in patients with cirrhosis. Furthermore, we expect to detect changes in liver and spleen stiffness as measured by MR-Elastography (MRE) after NSBB and that these depend on the drug-related effects on portal pressure.
Study design and patients:
39 patients with cirrhosis and esophageal varices that require NSBB (propranolol) treatment.
Patients are assessed with LVC, MR-scans, echocardiography and biochemical tests. LVC is the gold standard method to test if patients respond to propranolol treatment. At visit 1. the response to NSBB is defined as a reduction of HVPG ≥10%, or to a HVPG\< 12mmHg after intravenous NSBB administrations during LVC. MRI-scan with intraveneus NSBB administration is performed at visit 2. Minimum 5 days of NSBB wash out between visit 1 and 2.
MR-elastography and Phase Contrast MRI compared to LVC
150 studies on the registry are indexed under Esophageal and Gastric Varices; 39 are open to participants now.
This study's enrollment of 40 is below the median of 130 across 44 observational studies indexed under Esophageal and Gastric Varices.
Browse Esophageal and Gastric Varices studies →Hvidovre University Hospital is the lead sponsor of 299 studies on the registry; 20 are open to participants now.
Compared within Esophageal and Gastric Varices, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Hypertension, Portal. The counts are of registry records indexed under each term, refreshed daily. How we classify →
39 patients with cirrhosis and esophageal varices that require NSBB (propranolol) treatment.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NSBB response defined as a reduction in HVPG >10% or HVPG <12 mmHG after intraveneus NSBB administrations compared to flow (mL/min) in splanchnic vessels
To assess if changes in MR flow induced with NSBB (propranolol) administrations can predict the changes in HVPG after NSBB administration (NSBB respons) assessed by LVC
Time frame: after 20 minutes respons time
MR-elastography
To assess the liver and spleen stiffness (kPa) with MRE before and after intraveneus NSBB administration
Time frame: after 20 minutes
Plan to share: Undecided
Ran from Apr 2017 to primary completion in Dec 2020, 44 months.
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This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Esophageal and Gastric Varices →
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