Liver CirrhosisPhase 4PEKASYSNCT00332904
Effect of Betablocker or Aldosterone Antagonist Therapy on Patients With Liver Cirrhosis
A Phase 4 study testing propranolol and spironolactone in people with Liver Cirrhosis and Portal Hypertension, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
The study´s purpose is to investigate the effect of beta blockade or aldosterone antagonist therapy on oxygenation, peripheral and cardiac hemodynamics and humoral systems, in patients with liver cirrhosis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Cirrhosis, Portal Hypertension
- What is being tested?
- propranolol and spironolactone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2006to Dec 2010
- 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
- Liver cirrhosis
- Clinical indication for treatment with betablocker or aldosterone antagonist
- Must not have been treated earlier with betablocker or aldosterone antagonist
- Must have been alcohol abstinent for more than 4 weeks
Who cannot join
- Gastrointestinal bleeding in the last 2 weeks
- Encephalopathy > grade 1
- Acute medical conditions
- Malignant disease
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Clinical Physiology and Nuclear Medicine, and Department for Gastrointestinal Medicine, Hvidovre Hospital
Hvidovre, 2650
About this study
Official title: Effect of Betablocker or Aldosterone Antagonist Therapy on Oxygenation, Peripheral and Cardiac Hemodynamics and Humoral Systems
The study´s purpose is to investigate the effect of beta blockade or aldosterone antagonist therapy on oxygenation, peripheral and cardiac hemodynamics and humoral systems, in patients with liver cirrhosis.
Read the detailed description
Cardio-pulmonal complications to patients with liver cirrhosis and portal hypertension determine the patients' prognosis. Most patients have hemodynamical changes in circulation with increased cardiac output and decreased systolic function in stress. Endothelial dysfunction is a parameter for bad prognosis in cardiovascular disease. The Renin-angiotensin-aldosterone-system plays an important role in natrium and volume regulation. Descriptions of changes in the peripheral circulation and oxygenation have been deficient up to now.
Patients with liver cirrhosis and portal hypertension are betablockers and/or aldosterone antagonists routine treatment - effects on peripheral hemodynamics and oxygenation in relation to central hemodynamic changes are deficient.
- Conditions
- Liver Cirrhosis, Portal Hypertension
- Being tested
- propranolol, spironolactone
- Keywords
- betablocker, aldosterone antagonist, peripheral haemodynamics, cardiac haemodynamics, oxygenation
- Medical subject headings
- Liver Cirrhosis, Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propranololDrug
tablet 80 mg pr. day in a period of 3 weeks, evt. dose adjustment
spironolactoneDrug
tablet 200 mg pr. day in 3 weeks, evt. dose adjustment
| Study group | Role | What they receive |
|---|---|---|
| beta | Active comparator | patients with liver cirrhosis, treated with betablocker Receives: Drug: propranolol |
| spiron | Active comparator | patients with liver cirrhosis, treated with aldosterone antagonist Receives: Drug: spironolactone |
| control | No intervention | patients with liver cirrhosis, no treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
effect of treatment on hemodynamic and cardiac parameters
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2006 (estimated)
- Study startAug 2006
- Primary completionJul 2008
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Soeren Moeller, MD, DMSc, Study director, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00332904
- Sponsor's protocol ID
- CD-0606-HH-UH-DK
- Acronym
- PEKASYS
- Status last verified
- Jun 2010
- First submitted
- 31 May 2006
- Last updated
- 4 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Betablocker or Aldosterone Antagonist Therapy on Oxygenation, Peripheral and Cardiac Hemodynamics and Humoral Systems
- ClinicalTrials.gov ID
- NCT00332904
- Acronym / sponsor ID
- PEKASYS / CD-0606-HH-UH-DK
- Conditions
- Liver Cirrhosis, Portal Hypertension
- Keywords
- betablocker, aldosterone antagonist, peripheral haemodynamics, cardiac haemodynamics, oxygenation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- Jul 2008 (actual)
- Study completion
- Dec 2010 (estimated)
- First posted
- 2 Jun 2006 (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 study´s purpose is to investigate the effect of beta blockade or aldosterone antagonist therapy on oxygenation, peripheral and cardiac hemodynamics and humoral systems, in patients with liver cirrhosis.
Detailed description
Cardio-pulmonal complications to patients with liver cirrhosis and portal hypertension determine the patients' prognosis. Most patients have hemodynamical changes in circulation with increased cardiac output and decreased systolic function in stress. Endothelial dysfunction is a parameter for bad prognosis in cardiovascular disease. The Renin-angiotensin-aldosterone-system plays an important role in natrium and volume regulation. Descriptions of changes in the peripheral circulation and oxygenation have been deficient up to now.
Patients with liver cirrhosis and portal hypertension are betablockers and/or aldosterone antagonists routine treatment - effects on peripheral hemodynamics and oxygenation in relation to central hemodynamic changes are deficient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| beta | Active comparator | Drug: propranololpatients with liver cirrhosis, treated with betablocker |
| spiron | Active comparator | Drug: spironolactonepatients with liver cirrhosis, treated with aldosterone antagonist |
| control | No intervention | –patients with liver cirrhosis, no treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Liver cirrhosis
- Clinical indication for treatment with betablocker or aldosterone antagonist
- Must not have been treated earlier with betablocker or aldosterone antagonist
- Must have been alcohol abstinent for more than 4 weeks
Key exclusion criteria (5 listed)
- Gastrointestinal bleeding in the last 2 weeks
- Encephalopathy > grade 1
- Acute medical conditions
- Malignant disease
- Pregnancy
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 |
|---|---|---|
| propranololtablet 80 mg pr. day in a period of 3 weeks, evt. dose adjustment | Drug | beta |
| spironolactonetablet 200 mg pr. day in 3 weeks, evt. dose adjustment | Drug | spiron |
Primary outcome
effect of treatment on hemodynamic and cardiac parameters
Time frame: 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2010.
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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.
Soeren Moeller, MD, DMSc study director
Hvidovre University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing propranolol and spironolactone in people with Liver Cirrhosis and Portal Hypertension, run by Hvidovre University Hospital at 1 site in Denmark.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 4 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
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?
effect of treatment on hemodynamic and cardiac parameters (time frame: 3 weeks). 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 4 Jun 2010.