Ignite Creation Date:
2024-05-06 @ 9:56 AM
Last Modification Date:
2024-10-26 @ 12:22 PM
Study NCT ID:
NCT03114813
Status:
UNKNOWN
Last Update Posted:
2018-05-08
First Post:
2017-01-13
Brief Title:
Can MRI Evaluate Beta-blocker Response in Portal Hypertension
Sponsor:
University of Nottingham
Organization:
University of Nottingham
Study Overview
Official Title:
Beta-blocker Stratification Using Quantitative MRI Techniques to Assess Portal Pressure and Response to Treatment in Patients With Portal Hypertension
Status:
UNKNOWN
Status Verified Date:
2018-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
B-SMaRT
Brief Summary:
Aim
To test if MRI can detect meaningful changes in portal pressure in the liver to assess whether treatment with beta-blockers has worked
Liver Disease
Most people with liver disease do not have symptoms Over time they develop cirrhosis - severe liver scarring In the United Kingdom deaths due to cirrhosis have doubled over the last decade because of increasing rates of alcohol consumption and obesity while heart kidney lung diseases strokes and cancer fatalities have fallen
Portal pressure
Cirrhosis causes increased pressure within the liver and changes in the circulation leading to the development of varicose veins in the gullet and stomach called varices Varices bleed easily leading to emergency situations that can be life threatening However if the increased pressure within the liver portal pressure is detected early then treatment can prevent variceal bleeding The only test we have to predict prognosis and treatment success in someone with cirrhosis is by measuring the portal pressure
Measuring portal pressure
Currently the only existing test to measure portal pressure is to pass a pressure sensor through a vein in the neck down into the liver This is called the hepatic venous pressure gradient HVPG measurement The HVPG measurement is disliked by patients because it is an invasive procedure It is also expensive and not widely available Hence patients with cirrhosis need to have regular camera tests endoscopies to look for varices
How can you treat varices
Two options
1 With tablets to lower the pressure beta-blockers
2 Endoscopy treatment banding
Both have advantages and disadvantages
Beta-blockers only lower the portal pressure in about half of those that take them with some evidence they may also have a protective effect against infections from the bowel by increasing the speed of bowel motion
Treating the varices with endoscopy requires several endoscopies and can lead to life-threatening bleeding
Most patients are therefore given beta-blockers and monitored closely to see if they work
Why does it matter
Beta-blockers can cause side effects eg fainting that are unpleasant enough to make up to one third of patients stop taking them Beta-blockers only reduce the portal pressure in half of patients The remaining patients are exposed to potential side effects and possible harm in those with the most advanced liver disease These patients may still have a life-threatening bleed as the varices have not been adequately treated There is a desperate need to discover whether the portal pressure changes with treatment such as with beta-blockers without invasive tests across the NHS
Proposed study
Researchers in Nottingham have shown MRI can be used as an accurate marker of portal pressure with just one scan To be useful to patients doctors and researchers this study will investigate whether MRI can detect meaningful changes in portal pressure after treatment with beta-blockers This study has been designed with patient and public involvement PPI integrated throughout A focus group shaped the study design and committed to collaborate in developing patient materials recruitment retention and dissemination
All patients who have HVPG will be given information about the study
Study Visit 1
One hour MRI scan
Endoscopy to identify varices
If varices are present the patient will be started on beta-blockers and invited to visit 2
If there are no varices patients will return to regular follow up with the liver team
Study Visit 2 after one week
Assess side effects blood pressure and pulse
Increase dose of beta-blocker as appropriate
Study Visit 3 after 4-12 weeks
One hour MRI scan
Repeat HVPG measurement
Treatment success is determined by the second HVPG measurement If beta-blockers are working they will be continued If not the patient will have treatment with endoscopy This represents the ideal pathway which is more personalised than current standard care
To test if MRI can detect meaningful changes in portal pressure in the liver to assess whether treatment with beta-blockers has worked
Liver Disease
Most people with liver disease do not have symptoms Over time they develop cirrhosis - severe liver scarring In the United Kingdom deaths due to cirrhosis have doubled over the last decade because of increasing rates of alcohol consumption and obesity while heart kidney lung diseases strokes and cancer fatalities have fallen
Portal pressure
Cirrhosis causes increased pressure within the liver and changes in the circulation leading to the development of varicose veins in the gullet and stomach called varices Varices bleed easily leading to emergency situations that can be life threatening However if the increased pressure within the liver portal pressure is detected early then treatment can prevent variceal bleeding The only test we have to predict prognosis and treatment success in someone with cirrhosis is by measuring the portal pressure
Measuring portal pressure
Currently the only existing test to measure portal pressure is to pass a pressure sensor through a vein in the neck down into the liver This is called the hepatic venous pressure gradient HVPG measurement The HVPG measurement is disliked by patients because it is an invasive procedure It is also expensive and not widely available Hence patients with cirrhosis need to have regular camera tests endoscopies to look for varices
How can you treat varices
Two options
1 With tablets to lower the pressure beta-blockers
2 Endoscopy treatment banding
Both have advantages and disadvantages
Beta-blockers only lower the portal pressure in about half of those that take them with some evidence they may also have a protective effect against infections from the bowel by increasing the speed of bowel motion
Treating the varices with endoscopy requires several endoscopies and can lead to life-threatening bleeding
Most patients are therefore given beta-blockers and monitored closely to see if they work
Why does it matter
Beta-blockers can cause side effects eg fainting that are unpleasant enough to make up to one third of patients stop taking them Beta-blockers only reduce the portal pressure in half of patients The remaining patients are exposed to potential side effects and possible harm in those with the most advanced liver disease These patients may still have a life-threatening bleed as the varices have not been adequately treated There is a desperate need to discover whether the portal pressure changes with treatment such as with beta-blockers without invasive tests across the NHS
Proposed study
Researchers in Nottingham have shown MRI can be used as an accurate marker of portal pressure with just one scan To be useful to patients doctors and researchers this study will investigate whether MRI can detect meaningful changes in portal pressure after treatment with beta-blockers This study has been designed with patient and public involvement PPI integrated throughout A focus group shaped the study design and committed to collaborate in developing patient materials recruitment retention and dissemination
All patients who have HVPG will be given information about the study
Study Visit 1
One hour MRI scan
Endoscopy to identify varices
If varices are present the patient will be started on beta-blockers and invited to visit 2
If there are no varices patients will return to regular follow up with the liver team
Study Visit 2 after one week
Assess side effects blood pressure and pulse
Increase dose of beta-blocker as appropriate
Study Visit 3 after 4-12 weeks
One hour MRI scan
Repeat HVPG measurement
Treatment success is determined by the second HVPG measurement If beta-blockers are working they will be continued If not the patient will have treatment with endoscopy This represents the ideal pathway which is more personalised than current standard care
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None