Study on B-blockers to Prevent Decompensation of Cirrhosis With HTPortal (NCT01059396) | Clinical Trial Compass
CompletedPhase 4
Study on B-blockers to Prevent Decompensation of Cirrhosis With HTPortal
Spain201 participantsStarted 2010-01-28
Plain-language summary
This is a multicenter, randomized, double-blind, placebo-controlled study on the effectiveness of treatment with beta-blockers to prevent decompensation of cirrhosis with portal hypertension.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Between 18 and 80 years old.
* With liver cirrhosis diagnosed by previous biopsy or by clinical criteria, and analytical image.
* No esophageal varices (or with small varices without red signs) in a recent videogastroscophy (\<3 months before randomization).
* Absence of ascites demonstrated by a recent ultrasound (\<3 months before the randomization).
* informed consent
Exclusion Criteria:
* previous decompensation of liver cirrhosis associated with portal hypertension.
* GPVH \<10 mmHg.
* Portal axis thrombosis affecting the portal trunk or main hepatic branches, or the splenic or mesenteric vein.
* Hepatocellular carcinoma demonstrated by two imaging tests.
* Bilirubin\> 3 mg / dl (or\> 50 micromol / l), platelets \<30 x10E9/lo Quick \<30%.
* Presence of renal insufficiency (serum creatinine\> 2 mg / dl or\> 200 micromol / l).
* Any comorbidity involving a therapeutic limitation and / or a prognosis of life \<12 months.
* Absolute contraindication to treatment with β-blockers (severe bronchospasm, stenosis aortic A-V block, intermittent claudication, severe psychosis, bronchial asthma)
* Hypersensitivity to β-blockers.
* Pregnancy or lactation.
* To receive anticoagulant treatment.
* Past treatment with nitrated or β-blockers in the two weeks prior inclusion.
* Cirrhosis C virus active antiviral therapy.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Appearance of complications of portal hypertension: bleeding (caused by portal hypertension gastropathy and / or esophageal varices), ascites and / or spontaneous bacterial peritonitis(PBE), hepatic encephalopathy. Death from any cause.
Timeframe: 3 years
Trial details
NCT IDNCT01059396
SponsorFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau