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Treatment for Prevention of Variceal Rebleeding Guided by the Hemodynamic Response

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ClinicalTrials.gov Identifier: NCT00563602
Recruitment Status : Unknown
Verified November 2007 by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
Recruitment status was:  Recruiting
First Posted : November 26, 2007
Last Update Posted : November 26, 2007
Sponsor:
Information provided by:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study Description
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Brief Summary:

This is a prospective trial of random distribution, open, parallel group, in which patients with esophagic variceal bleeding will be randomized into two treatment groups, after controlling acute bleeding. All patients received standard medical therapy with b-blockers and endoscopic ligation (LEV) of esophageal varices.

The control group will be assigned to receive LEV + Nadolol + MNI. The experimental group will be assigned to receive treatment according to the hemodynamic response.

All patients included in the experimental group received LEV and pharmacological treatment nadolol alone or combined with MNI or Prazosin (PZ)


Condition or disease Intervention/treatment Phase
Portal Hypertension Complications of Cirrhosis Other: Hemodynamic guided therapy Phase 4

Detailed Description:

This is a prospective trial of random distribution, open, parallel group, in which patients with esophagic variceal bleeding will be randomized into two treatment groups, after controlling acute bleeding. All patients received standard medical therapy with b-blockers and endoscopic ligation (LEV) of esophageal varices.

The control group will be assigned to receive LEV + Nadolol (N) + Isosorbide Mononitrate (MNI) The experimental group will be assigned to receive treatment according to the hemodynamic response.

All patients included in the experimental group received LEV and pharmacological treatment nadolol alone or combined with MNI or Prazosin (PZ)

A hepatic hemodynamic study will be performed to patients in both groups, at baseline (In which basal values and acute b-blockers response will be assessed), and a second study at the 3 rd -4 th week after the drug therapy start, after the titration of the doses.

In the experimental group, responders to the acute administration of b-blockers will receive LEV + Nadolol alone, and those patients with no response will receive LEV + N + MNI, and another hemodynamic study will be performed 3 rd -4 th week after the drug therapy start, after the titration of the doses, to assess response. The non-responders in this control study will switched to LEV+ N + PZ, and a 3erd hemodynamic study will be performed.

Randomization will be stratified according to the degree of hepatic insufficiency, assessed by the Child-Pugh classification (classes A and B vs C)

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Randomized and Controlled Study of Endoscopic Ligation, Nadolol and Isosorbide Mononitrate vs Endoscopic Ligation and Nadolol Alone, or Associated With Isosorbide Mononitrate or Prazosin, Depending of the Hemodinamyc Response
Study Start Date : August 2007
Estimated Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Nadolol

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 2
Standard Therapy: Endoscopic ligation (LEV) + Nadolol + Isosorbide mononitrate (MNI)(drugs carefully titrated until achieve maximum tolerated dose)
 Other: Hemodynamic guided therapy

To switch two or more different treatments for the prevention of variceal rebleeding according to the hemodynamic response. All patients in the experimental group will begin by:

1) LEV + Nadolol. HVPG measurement: if response, no changes, if not, switch to 2) LEV + Nadolol + MNI. HVPG measurement: if response, no changes, if not, switch to: 3) LEV + Nadolol + Prazosin. (drugs carefully titrated until achieve maximum tolerated dose)
Experimental: 1

Hemodynamic guided therapy:

1) LEV + Nadolol. HVPG measurement: if response, no changes, if not, switch to 2) LEV + Nadolol + MNI. HVPG measurement: if response, no changes, if not, switch to: 3) LEV + Nadolol + Prazosin. (drugs carefully titrated until achieve maximum tolerated dose)

 Other: Hemodynamic guided therapy

To switch two or more different treatments for the prevention of variceal rebleeding according to the hemodynamic response. All patients in the experimental group will begin by:

1) LEV + Nadolol. HVPG measurement: if response, no changes, if not, switch to 2) LEV + Nadolol + MNI. HVPG measurement: if response, no changes, if not, switch to: 3) LEV + Nadolol + Prazosin. (drugs carefully titrated until achieve maximum tolerated dose)


Outcome Measures
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Primary Outcome Measures :
  1. Rebleeding [ Time Frame: 1-2 Years ]

Secondary Outcome Measures :
  1. Survival [ Time Frame: 1-2 Years ]
  2. Adverse effects [ Time Frame: 1-2 Years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All the patients admitted in emergencies in which 1) with gastrointestinal bleeding due to esophageal varices assessed by endoscopy, will be included.
  • We define esophagic variceal bleeding as the endoscopic finding of any the following signs: 1) active variceal bleeding 2) clot or platelet cluster or 3 ) esophageal varices associated to red blood in esophagogastric lumen in the absence of other sources of bleeding.
  • Clinical criteria and / or analytical, ultrasound and / or liver biopsy consistent with the diagnosis of liver cirrhosis.
  • Written informed consent to participate in the study.
  • Patients in fertile age should use barrier methods to prevent pregnancy during the entire study. The pregnancy test prior to the study must be negative

Exclusion Criteria:

  • Age <18 or> 80 years.
  • Patients not eligible for active treatment due to any underlying morbid condition (terminals). Here are included those patients with advanced liver disfunction (Child-Pugh >) or any patient with life expectancy < 6 mo.
  • Refuse to participate in the study.
  • Bleeding due to causes other than the esophageal varices.
  • Prior inclusion in this study.
  • Failure in the control of the acute bleeding (index episode).
  • Pretreatment through elective LEV program, sclerotherapy or combined β- blockers plus nitrates, or portosystemic shunt (surgical or percutaneous).
  • Contraindication for β- blockers and MNI (not exclude patients with contraindication for one of these drugs) or endoscopic procedures.
  • Pregnancy.
  • Presence multiple hepatocellular carcinoma or only diameter > 5 cm.
  • Portal vein thrombosis.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00563602


Contacts
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Contact: Candid Villanueva, MD +34620955006 cvillanueva@santpau.es
Contact: Jordi Virgili

Locations
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Spain
HospitalSCSP Recruiting
Barcelona, Spain, 08025
Contact: Candid Villanueva, MD    +34620955006    cvillanueva@santpau.es   
Principal Investigator: Candid Villanueva, MD         
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Investigators
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Principal Investigator: Candid Villanueva, MD Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
More Information
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ClinicalTrials.gov Identifier: NCT00563602    
Other Study ID Numbers: CONHEMO-2006
EudraCT 2007-002237-37
First Posted: November 26, 2007    Key Record Dates
Last Update Posted: November 26, 2007
Last Verified: November 2007
Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:
Portal hypertension
Prevention of rebleeding
Complications of cirrhosis
Portal hemodynamic
 Prazosine
Nadolol
isosorbide mononitrate
Additional relevant MeSH terms:
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Hypertension, Portal
Hypertension
Fibrosis
Vascular Diseases
 Cardiovascular Diseases
Pathologic Processes
Liver Diseases
Digestive System Diseases