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

F

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

Status and phase

Completed
Phase 4

Conditions

Portal Hypertension Gastropathy
Hepatic Encephalopathy
Esophageal Varices
Spontaneous Bacterial Peritonitis
Ascites

Treatments

Drug: placebo
Drug: propranolol
Drug: carvedilol

Study type

Interventional

Funder types

Other

Identifiers

NCT01059396
PREDESCI

Details and patient eligibility

About

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.

Enrollment

201 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

201 participants in 3 patient groups, including a placebo group

Propranolol
Experimental group
Treatment:
Drug: propranolol
carvedilol
Experimental group
Treatment:
Drug: carvedilol
Placebo
Placebo Comparator group
Treatment:
Drug: placebo

Trial contacts and locations

8

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Data sourced from clinicaltrials.gov

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