HVPG for Rebleeding Risk Stratification

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jaime Bosch, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT01751191
First received: December 13, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
  Purpose

Background: In patients with cirrhosis on secondary prevention of variceal rebleeding with non-selective beta-blockers (NSBBs), the risk of rebleeding and death is markedly higher in those failing to achieve a good hemodynamic response (HVPG reduction ≥20% of baseline values or ≤12mmHg). However a substantial proportion of non-responders will never rebleed, thus appearing protected by NSBBs although non-detected by HVPG response. This low sensitivity hampers risk stratification and diminishes the cost-effectiveness of assessing the hemodynamic response to NSBBs. This is particularly relevant in prevention of rebleeding since in this scenario the risk of rebleeding and of other portal hypertension related complications is very high, which calls for early institution of effective therapy.

Baseline HVPG bears prognostic significance with regards to risk of developing varices, decompensation, hepatocellular carcinoma and death1,2,7,8,18-27. However, no studies have investigated whether adding data from baseline HVPG may improve the sensitivity of the criteria defining a good or poor hemodynamic response.

Hypothesis: Adding data from baseline HVPG may improve the sensitivity of the criteria defining a good or poor hemodynamic response.

Objective: Exploring the prognostic value of basal HVPG that better discriminate those non-responders who do not re-bleed under prophylactic treatment with NSBBs.

Methods: Observational cohort study. Training set: patients from two longitudinal studies conducted at the Hepatic Hemodynamic laboratory of the Hospital Clínic of Barcelona to assess the prognostic value of HVPG changes during continuous therapy with NSBBs for preventing variceal rebleeding. Validation set for chronic hemodynamic response: patients from two longitudinal studies conducted at the Hepatic Hemodynamic laboratory of the Hospital de Sant Pau of Barcelona to assess the prognostic value of HVPG changes during continuous therapy with NSBBs for preventing variceal rebleeding; a third cohort composed of patients undergoing acute hemodynamic response to intravenous propranolol will be studied.

All patients received a preplanned follow-up in the outpatient clinic at 1, 3, and 6 months, and every 6 months thereafter in the original studies.

End-point: bleeding from portal hypertensive sources (esophago-gastric varices or portal hypertensive gastropathy) (defined according to Baveno criteria 32), death or liver transplantation.

Ethical aspects: All patients have given their written informed consent to use their data in the original studies.


Condition
Liver Cirrhosis
Portal Hypertension

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study Protocol: Observational Cohort Study to Improve Rebleeding Risk Stratification for Patients With Cirrhosis and Portal Hypertension on Non-selective Beta-blockers

Resource links provided by NLM:


Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • bleeding from portal hypertensive sources (esophago-gastric varices or portal hypertensive gastropathy), death or liver transplantation. [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Enrollment: 338
Study Start Date: August 2011
Study Completion Date: December 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Training set-chronic response to propranolol
Validation set-chronic response to propranolol
Acute response to propranolol

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with liver cirrhosis who already experienced a esophageal variceal bleeding, requiring therapy with non-selective beta-blockers for their portal hypertension.

Criteria

Inclusion Criteria:

Liver Cirrhosis Admission for bleeding from esophageal varices in the previous 7 days Baseline HVPG >12 mmHg Subsequent long-term treatment with NSBB (propranolol or nadolol) Second measurement of HVPG after 1-3 months of therapy

Exclusion Criteria:

Hepatocellular carcinoma Portal vein thrombosis Contraindications to beta-blockers Cholestatic liver disease

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01751191

Locations
Spain
Hospital Clinic
Barcelona, Spain, 08036
Hospital de Sant Pau
Barcelona, Spain
Sponsors and Collaborators
Hospital Clinic of Barcelona
  More Information

No publications provided

Responsible Party: Jaime Bosch, Prof., Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT01751191     History of Changes
Other Study ID Numbers: PREDICT16
Study First Received: December 13, 2012
Last Updated: December 13, 2012
Health Authority: Spain: Comité Ético de Investigación Clínica del Hospital Clínic de Barcelona

Additional relevant MeSH terms:
Hypertension
Liver Cirrhosis
Hypertension, Portal
Vascular Diseases
Cardiovascular Diseases
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 30, 2014