Alcoholic Liver CirrhosisPhase 4NCT00239096
Prevention of Decompensation in Liver Cirrhosis
A Phase 4 study testing losartan (drug) in people with Alcoholic Liver Cirrhosis and Ascites, run by Odense University Hospital at 1 site in Denmark.
Trial summary
The purpose of this study is to determine whether losartan, an angiotensin II blocker prevents the sodium retention in patients with liver cirrhosis and by that reduces the fluid retention. Moreover is the purpose to asses whether losartan is antifibrotic. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Alcoholic Liver Cirrhosis, Ascites
- What is being tested?
- losartan (drug)
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2005to Sep 2011
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The presence of cirrhosis in a liver biopsy; or, in the absence of histology, clinical and laboratory evidence of cirrhosis combined with years of excessive alcohol intake.
- Age 18-70 years
Who cannot join
- Cirrhosis due to alpha1-antitrypsin deficiency, viral hepatitis or autoimmunity.
- Renal disease evidenced by proteinuria > 0,5 g/day.
- Heart disease
- Hypertension
- Cancer or disease other than cirrhosis expected to limit life expectancy to < 5 years.
- Pregnancy or lactation
- Sepsis within 5 days
- Gastrointestinal bleeding within 5 days
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Odense University Hospital
Odense, Odense, 5000
Ove B Schaffalitzky de Muckadell, Professor, 0045 65412750, sdm@ouh.fyns-amt.dk
Annette Dam, MD
About this study
Official title: Losartan in the Prevention of Sodium Retention and Ascites in Liver Cirrhosis - a Prospective Randomized Long-Term Study
The purpose of this study is to determine whether losartan, an angiotensin II blocker prevents the sodium retention in patients with liver cirrhosis and by that reduces the fluid retention. Moreover is the purpose to asses whether losartan is antifibrotic.
Read the detailed description
Patients with cirrhosis tend to retain sodium and water leading to the development of ascites, which in the terminal stage of decompensation cannot be eliminated despite the use of massive diuretic treatment. These decompensated patients have a very high mortality of 50 % within 3 years and morbidity, and until now no symptomatic treatment has been able to improve the prognosis.
It has been hypothesized that ascites and edema develop first due to renal sodium retention secondary to increased activity of hormones like angiotensin II and aldosterone, which may be stimulated by reduced arterial filling caused by systemic vasodilatation, and secondly due to liver fibrosis which may cause lymphatic overflow and formation of ascites.
Decreased central volume filling is believed to stimulate baroreceptors with activation of the renin-angiotensin-aldosterone system, the sympathetic nervous system and arginine vasopressin .
In cirrhotic patients systemic vasodilatation with hypotension, tachycardia, increased cardiac output and increased plasma volume has been thought to be caused by increased levels of vasodilating substances like nitric oxide (NO), but blocking NO synthesis using N(G)-monomethyl-L-arginine-acetate (L-NMMA) did not favorably influence renal sodium excretion, probably due to an important role of NOS in renal sodium handling .
It is evident that the pathophysiology of the development of excessive sodium and water retention in cirrhotic patients is insufficiently elucidated, and that an increased knowledge in this field may improve the therapeutic possibilities. Patients with cirrhosis without ascites have normal or increased glomerular filtration rate (GFR) and normal or suppressed plasma levels of renin, angiotensin II and aldosterone. Later renal blood flow and GFR may be decreased and patients have avid tubular sodium reabsorption as they can produce a virtually sodium-free urine. These functional renal changes regress after transplantation with a normal liver. Suggestions have been made that overfilling rather than central underfilling precede ascites formation. In any case blocking the mineralocorticoid receptor with spironolactone is an effective diuretic treatment in many cirrhotic patients, and this points to the importance of the distal part of the nephron in the mediation of excess sodium reabsorption.
Angiotensin II (ANG II) binds to the AT1 receptor localized to renal glomeruli and tubules, the adrenals and arterioles, not only efferent arterioles in the kidneys, but also resistance vessels of the systemic vasculature. In the adrenals ANG II stimulates aldosterone secretion. In addition it has been shown in rats that the expression of the vasopressin receptor V2 is upregulated by ang II, an effect expected to increase water reabsorption (10). Most likely ANG II aggravates the portal hypertension due to stimulation of stellate myofibroblasts, and this may be part of the circulus vitiosus which should be broken in cirrrhosis. In another volume retaining disorder - heart failure - blockade of the renin angiotensin aldosterone system has been shown to be extremely effective in retarding progression of the disease.
Treatment of cirrhotic patients with ACE-inhibitors has been tried but was poorly tolerated since blood pressure and GFR decreased. In one study, however, the addition of a low dose of Captopril to furosemide and spironolactone increased natriuresis in half the patients . It could be expected that an ANG II blocker would be better tolerated in cirrhotic patients, because bradykinin metabolism, and the production of NO and prostaglandins are not affected. Accordingly three recent studies have shown that low dose ANG II receptor type I blocking increased sodium excretion in cirrhotic patients without affecting systemic or renal hemodynamics, also in patients with normal systemic levels of renin-angiotensin-aldosterone. Losartan at a dose of 7.5 mg was able to counteract the sodium retention otherwise demonstrated in preascitic patients going from supine to standing position . Low dose Losartan could inhibit sodium retention when preascitic patients were given a high sodium diet . Losartan given at a higher dose -25 mg daily - to both preascitic and ascitic patients increased GFR and natriuresis without affection of blood pressure . In contrast to some previous results Schneider et al found that Losartan was able to reduce the portal pressure of cirrhotic patients at a dose at which the systemic circulation was not adversely affected, and even a natriuretic effect could be demonstrated . Accordingly a reducing effect of the ANG II antagonist Irbesartan has been demonstrated . Unfortunately an ameliorating effect of ANG II antagonists on portal pressure without adverse effects on blood pressure could not be demonstrated in two recent studies. A long-term (years) longitudinal study of cirrhotic patients with registration of consecutive changes in sodium handling, systemic and renal hemodynamics and neurohumoral regulations has never been done but is likely to elucidate the pathophysiology in these patients. In addition it is hypothesized that early intervention with the ANG II receptor antagonist Losartan could delay or even prevent development of the decompensated stage and thus improve survival and quality of life in these patients.
- Conditions
- Alcoholic Liver Cirrhosis, Ascites
- Being tested
- losartan (drug)
- Keywords
- alcoholic liver cirrhosis, ascites, sodium retention
- Medical subject headings
- Liver Cirrhosis, Alcoholic, Ascites, Hypernatremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
losartan (drug)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
Secondary outcomes (3)
varices
need for therapeutic ascites drainage
gastrointestinal bleeding episodes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2005 (estimated)
- Study startSep 2005
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcoholic Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe 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
- 100 participants
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Lundbeck Foundation, University of Southern Denmark, Else Poulsen Mindelegat
- Investigators
- Annette Dam, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00239096
- Sponsor's protocol ID
- VF20040245
- Other IDs
- Eudra CT: 2005-001191-12
- Status last verified
- Oct 2005
- First submitted
- 12 Oct 2005
- Last updated
- 14 Oct 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Losartan in the Prevention of Sodium Retention and Ascites in Liver Cirrhosis - a Prospective Randomized Long-Term Study
- ClinicalTrials.gov ID
- NCT00239096
- Acronym / sponsor ID
- VF20040245
- Conditions
- Alcoholic Liver Cirrhosis, Ascites
- Keywords
- alcoholic liver cirrhosis, ascites, sodium retention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- Lundbeck Foundation, University of Southern Denmark, Else Poulsen Mindelegat
- Study start
- Sep 2005
- Study completion
- Sep 2011
- First posted
- 14 Oct 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 purpose of this study is to determine whether losartan, an angiotensin II blocker prevents the sodium retention in patients with liver cirrhosis and by that reduces the fluid retention. Moreover is the purpose to asses whether losartan is antifibrotic.
Detailed description
Patients with cirrhosis tend to retain sodium and water leading to the development of ascites, which in the terminal stage of decompensation cannot be eliminated despite the use of massive diuretic treatment. These decompensated patients have a very high mortality of 50 % within 3 years and morbidity, and until now no symptomatic treatment has been able to improve the prognosis.
It has been hypothesized that ascites and edema develop first due to renal sodium retention secondary to increased activity of hormones like angiotensin II and aldosterone, which may be stimulated by reduced arterial filling caused by systemic vasodilatation, and secondly due to liver fibrosis which may cause lymphatic overflow and formation of ascites.
Decreased central volume filling is believed to stimulate baroreceptors with activation of the renin-angiotensin-aldosterone system, the sympathetic nervous system and arginine vasopressin .
In cirrhotic patients systemic vasodilatation with hypotension, tachycardia, increased cardiac output and increased plasma volume has been thought to be caused by increased levels of vasodilating substances like nitric oxide (NO), but blocking NO synthesis using N(G)-monomethyl-L-arginine-acetate (L-NMMA) did not favorably influence renal sodium excretion, probably due to an important role of NOS in renal sodium handling .
It is evident that the pathophysiology of the development of excessive sodium and water retention in cirrhotic patients is insufficiently elucidated, and that an increased knowledge in this field may improve the therapeutic possibilities. Patients with cirrhosis without ascites have normal or increased glomerular filtration rate (GFR) and normal or suppressed plasma levels of renin, angiotensin II and aldosterone. Later renal blood flow and GFR may be decreased and patients have avid tubular sodium reabsorption as they can produce a virtually sodium-free urine. These functional renal changes regress after transplantation with a normal liver. Suggestions have been made that overfilling rather than central underfilling precede ascites formation. In any case blocking the mineralocorticoid receptor with spironolactone is an effective diuretic treatment in many cirrhotic patients, and this points to the importance of the distal part of the nephron in the mediation of excess sodium reabsorption.
Angiotensin II (ANG II) binds to the AT1 receptor localized to renal glomeruli and tubules, the adrenals and arterioles, not only efferent arterioles in the kidneys, but also resistance vessels of the systemic vasculature. In the adrenals ANG II stimulates aldosterone secretion. In addition it has been shown in rats that the expression of the vasopressin receptor V2 is upregulated by ang II, an effect expected to increase water reabsorption (10). Most likely ANG II aggravates the portal hypertension due to stimulation of stellate myofibroblasts, and this may be part of the circulus vitiosus which should be broken in cirrrhosis. In another volume retaining disorder - heart failure - blockade of the renin angiotensin aldosterone system has been shown to be extremely effective in retarding progression of the disease.
Treatment of cirrhotic patients with ACE-inhibitors has been tried but was poorly tolerated since blood pressure and GFR decreased. In one study, however, the addition of a low dose of Captopril to furosemide and spironolactone increased natriuresis in half the patients . It could be expected that an ANG II blocker would be better tolerated in cirrhotic patients, because bradykinin metabolism, and the production of NO and prostaglandins are not affected. Accordingly three recent studies have shown that low dose ANG II receptor type I blocking increased sodium excretion in cirrhotic patients without affecting systemic or renal hemodynamics, also in patients with normal systemic levels of renin-angiotensin-aldosterone. Losartan at a dose of 7.5 mg was able to counteract the sodium retention otherwise demonstrated in preascitic patients going from supine to standing position . Low dose Losartan could inhibit sodium retention when preascitic patients were given a high sodium diet . Losartan given at a higher dose -25 mg daily - to both preascitic and ascitic patients increased GFR and natriuresis without affection of blood pressure . In contrast to some previous results Schneider et al found that Losartan was able to reduce the portal pressure of cirrhotic patients at a dose at which the systemic circulation was not adversely affected, and even a natriuretic effect could be demonstrated . Accordingly a reducing effect of the ANG II antagonist Irbesartan has been demonstrated . Unfortunately an ameliorating effect of ANG II antagonists on portal pressure without adverse effects on blood pressure could not be demonstrated in two recent studies. A long-term (years) longitudinal study of cirrhotic patients with registration of consecutive changes in sodium handling, systemic and renal hemodynamics and neurohumoral regulations has never been done but is likely to elucidate the pathophysiology in these patients. In addition it is hypothesized that early intervention with the ANG II receptor antagonist Losartan could delay or even prevent development of the decompensated stage and thus improve survival and quality of life in these patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The presence of cirrhosis in a liver biopsy; or, in the absence of histology, clinical and laboratory evidence of cirrhosis combined with years of excessive alcohol intake.
- Age 18-70 years
Key exclusion criteria (8 listed)
- Cirrhosis due to alpha1-antitrypsin deficiency, viral hepatitis or autoimmunity.
- Renal disease evidenced by proteinuria > 0,5 g/day.
- Heart disease
- Hypertension
- Cancer or disease other than cirrhosis expected to limit life expectancy to < 5 years.
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 |
|---|---|---|
| losartan (drug) | Drug | – |
Primary outcome
Death
3 secondary outcomes
varices
need for therapeutic ascites drainage
gastrointestinal bleeding episodes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2005.
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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.
Annette Dam, MD principal investigator
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 losartan (drug) in people with Alcoholic Liver Cirrhosis and Ascites, run by Odense 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 2 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: status not confirmed, as of the sponsor's last update on 14 Oct 2005. 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?
Contact Ove B. Schaffalitzky de Muckadell, Professor (0045 65412750, sdm@ouh.fyns-amt.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death. 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 14 Oct 2005.