Alcoholic CirrhosisPhase 4NCT00188045
Hemodynamic Effects of Chronic Administration of Spironolactone and/or Propranolol in Alcoholic Cirrhotic Patients
A Phase 4 study testing Propranolol - Spironolactone in people with Alcoholic Cirrhosis, run by University Hospital, Angers.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Alcoholic Cirrhosis
- What is being tested?
- Propranolol - Spironolactone
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- Apr 1995to Dec 2003
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Indication of transjugular hepatic biopsy
- alcoholic cirrhosis
- presence of oesophageal varices ≤ stade 2
Who cannot join
- 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
About this study
Official title: Hemodynamic Effects of Chronic Administration of Spironolactone, Propranolol and Their Association in Alcoholic Cirrhotic Patients
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.
- Conditions
- Alcoholic Cirrhosis
- Being tested
- Propranolol - Spironolactone
- Keywords
- Portal hypertension, alcoholic cirrhosis, Hepatic venous pressure gradient, hemodynamic, spironolactone, propranolol
- Medical subject headings
- Liver Cirrhosis, Alcoholic, Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propranolol - SpironolactoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of hepatic veinous pressure gradient changes after chronic treatment by spironolactone or propranolol alone or in association.
Secondary outcomes (1)
Efficacy of spironolactone/propranolol association
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startApr 1995
- Study completionDec 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcoholic CirrhosisStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 54 participants
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Investigators
- Paul Cales, PHD, Principal investigator, UH Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00188045
- Sponsor's protocol ID
- PHRC 01-13
- Status last verified
- Dec 2001
- First submitted
- 12 Sep 2005
- Last updated
- 1 Nov 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Effects of Chronic Administration of Spironolactone, Propranolol and Their Association in Alcoholic Cirrhotic Patients
- ClinicalTrials.gov ID
- NCT00188045
- Acronym / sponsor ID
- PHRC 01-13
- Conditions
- Alcoholic Cirrhosis
- Keywords
- Portal hypertension, alcoholic cirrhosis, Hepatic venous pressure gradient, hemodynamic, spironolactone, propranolol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 54 participants
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Apr 1995
- Study completion
- Dec 2003
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Indication of transjugular hepatic biopsy
- alcoholic cirrhosis
- presence of oesophageal varices ≤ stade 2
Key exclusion criteria (8 listed)
- renal insufficiency
- natremia ≤ 135 mmol/l
- vasoactive treatment in the last month before inclusion
- hepatocellular carcinoma
- positive HIV and HCV patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Propranolol - Spironolactone | Drug | – |
Primary outcome
assessment of hepatic veinous pressure gradient changes after chronic treatment by spironolactone or propranolol alone or in association.
1 secondary outcome
Efficacy of spironolactone/propranolol association
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Cales, PHD principal investigator
UH Angers
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Propranolol - Spironolactone in people with Alcoholic Cirrhosis, run by University Hospital, Angers.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assessment of hepatic veinous pressure gradient changes after chronic treatment by spironolactone or propranolol alone or in association.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2017.