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HVPG for Rebleeding Risk Stratification

NCT ID: NCT01751191

Last Updated: 2012-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

338 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Liver Cirrhosis Portal Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Training set-chronic response to propranolol

No interventions assigned to this group

Validation set-chronic response to propranolol

No interventions assigned to this group

Acute response to propranolol

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Clinic of Barcelona

OTHER

Sponsor Role lead

Responsible Party

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Jaime Bosch

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital Clinic

Barcelona, , Spain

Site Status

Hospital de Sant Pau

Barcelona, , Spain

Site Status

Countries

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Spain

Other Identifiers

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PREDICT16

Identifier Type: -

Identifier Source: org_study_id