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Hemodynamic Effects of Chronic Administration of Spironolactone and/or Propranolol in Alcoholic Cirrhotic Patients

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ClinicalTrials.gov Identifier: NCT00188045
Recruitment Status : Terminated
First Posted : September 16, 2005
Last Update Posted : November 1, 2017
Sponsor:
Information provided by:
University Hospital, Angers

Tracking Information
First Submitted Date  ICMJE September 12, 2005
First Posted Date  ICMJE September 16, 2005
Last Update Posted Date November 1, 2017
Study Start Date  ICMJE April 1995
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
assessment of hepatic veinous pressure gradient changes after chronic treatment by spironolactone or propranolol alone or in association.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00188045 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
Efficacy of spironolactone/propranolol association
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hemodynamic Effects of Chronic Administration of Spironolactone and/or Propranolol in Alcoholic Cirrhotic Patients
Official Title  ICMJE Hemodynamic Effects of Chronic Administration of Spironolactone, Propranolol and Their Association in Alcoholic Cirrhotic Patients
Brief Summary The aim of this study was assesment of splanchnic and systemic hemodynamic effects of chronic administration (2 month) of spironolactone or propranolol, alone or in association in alcoholic cirrhotic patients. The patients were randomized in 4 groups (aldactone 150 mg/day, propranolol 160 mg/day, aldactone 150 mg/day + propranolol 160 mg/day, placebo). Systemic and splanchnic hemodynamic effect were evaluated by hepatic venous pressure gradient measurements before and after 2 month of treatment.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Condition  ICMJE Alcoholic Cirrhosis
Intervention  ICMJE Drug: Propranolol - Spironolactone
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Enrollment  ICMJE
 (submitted: September 12, 2005)
54
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE December 2003
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Indication of transjugular hepatic biopsy
  • alcoholic cirrhosis
  • presence of oesophageal varices ≤ stade 2

Exclusion Criteria:

  • renal insufficiency
  • natremia ≤ 135 mmol/l
  • vasoactive treatment in the last month before inclusion
  • hepatocellular carcinoma
  • positive HIV and HCV patients
  • paracentesis in the last week before inclusion
  • digestive bleeding in one last week
  • oesophageal varices stade 3 or 2 with red signs
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00188045
Other Study ID Numbers  ICMJE PHRC 01-13
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE University Hospital, Angers
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Paul Cales, PHD UH Angers
PRS Account University Hospital, Angers
Verification Date December 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP