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OpenTrials
Completed

NCT Number: NCT01059396

Study on B-blockers to Prevent Decompensation of Cirrhosis With HTPortal

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Propranolol

Drug

GPVH ≥ 10 mmHg - responders: propranolol.

Carvedilol

Drug

GPVH ≥ 10 mmHg nonresponders: carvedilol.

Placebo

Drug

placebo propranolol / carvedilol

Primary outcomes

  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.

    Time frame: 3 years

Secondary outcomes

  1. Compare the appearance of each of the complications of portal hypertension (ascites, SBP and other bacterial infections, varicose veins or signs of high risk, upper gastrointestinal bleeding portal hypertension, hepatic encephalopathy).

    Time frame: 3 years

  2. Assess the development of liver failure.

    Time frame: 3 years

  3. Quantify the adverse effects of treatment (occurrence and intensity, need to withdraw the treatment).

    Time frame: 3 years

  4. To assess survival.

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Other

Registry information

Official study title

Multicenter, Randomized, Double-blind, Placebo-controlled Study on the Effectiveness of Treatment With Beta-blockers to Prevent Decompensation of Cirrhosis With Portal Hypertension

Acronym: PREDESCI

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Jan 29, 2010
Registry last updated
Aug 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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