Hepatic CirrhosisALB-BETNCT02163512
Effect of Beta-adrenergic Blockers on Cardiac Function, Systemic and Splanchnic Haemodynamic and Kidney Function in Cirrhotic Patiets With Refractory Ascites
An observational study of Hepatic Cirrhosis, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 2 sites in Spain.
Trial summary
Multicentric, observational and prospective study with two groups of treatment: Refractory ascites and non-refractory ascites. All patients should be prescribed beta-adrenergic blockers as primary or secondary profilaxis for variceal bleeding. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatic Cirrhosis
- How many people
- 46 participants
- Where
- 2 sitesSpain
- Study dates
- 12 Mar 2014to May 2018
- Phase
- Observational
- 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
Study population: Patients with hepatic cirrhoris and refractory or non-refractory ascites. These patients are going to be treated with beta blockers as primary or secondary prophylaxis of variceal bleeding
Who may be able to join
- Patients aged 18-80
- Patients previously prescribed with beta-blockers
- Any type of hepatic cirrosis that has been diagnosed by clinical, analytic and image criteria
- Mild to serious ascites. Classification on refractory or non-refractory ascites depends on the patient´s response to diuretic treatment. Refractory ascites is defined by the Ascites´Board International Criteria as the lack of response, ascites recurrency or complications occurrence by diuretic drugs uptake
- Esophageal varicose vein in which beta blockers treatment is indicated as primary or secondary prophylaxis. Primary prophylaxis is indicated for big esophageal varicose veins, small varicose veins with red signs or varicose veins in patients with B-C Child-Pugh stage. Secondary prophylaxis is indicated for all those patients that have previously presented varicose bleeding.
- Patients giving a written consent to participate in the study after having received enough information about the design, objectives and risks.
Who cannot join
- Hepatocellular carcinoma >5 cm
- Total portal vein thrombosis or Cavernous transformation of the portal vein
- Insuficiencia renal (creatinina sérica >3 mg/dl).
- Kidney insufficiency (seric creatinine >3 mg/dl)
- Contraindications to beta-blockers: Cardiac or breathing insufficiency, auricular-ventricular blocking grade >1.
- Anticoagulant treatment
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- Patients with a intrahepatic portosystemic shunt
- Beta-blockers Hypersensitivity
- Pregnancy and breastfeeding
- Women of childbearing age must commit to undergo an effective contraception during the treatment and at least one month after finishing it.
- Patients with severe controlled or not controlled psychiatric condition
- Patients´ lack of commitment to follow all visits.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital Universitario Gregorio Marañón
Madrid, 28007
Hospital Universitario Ramón y Cajal
Madrid, 28034
About this study
Multicentric, observational and prospective study with two groups of treatment: Refractory ascites and non-refractory ascites. All patients should be prescribed beta-adrenergic blockers as primary or secondary profilaxis for variceal bleeding.
- Conditions
- Hepatic Cirrhosis
- Keywords
- Hepatic cirrhosis, Ascites, Beta blockers treatment
- Medical subject headings
- Liver Cirrhosis, Ascites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Non-refractory ascites | Not described | |
| Refractory ascites | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac function
- Echocardiography: changes in left ventricular ejection fraction, cardiac output,
- Electrocardiography: changes in Qt interval
Measured: Baseline and after 4 weeks
Kidney function
- Echocardiography: Renal vascular Doppler ultrasonographic parameters (resistive index of kidney arteries)
- Blood test: serum creatinine, estimated glomerular filtration rate (eGFR) calculated by the Modification of Diet in Renal Disease formula, IL18, KIM1, NGAL
Measured: Baseline and after 4 weeks
Secondary outcomes (1)
Inflammatory markers and vasoactive endogenous system
- Levels of monoaminergic systems: variations in activity of the autonomous nervous system (levels of renin, aldosterone and noradrenaline)
- Immune system activation: TNF-alpha, IL 6, TNFR I y II, LBP
Measured: Baseline and after 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2014 (estimated)
- Study start12 Mar 2014
- Primary completionMay 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatic 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02163512
- Sponsor's protocol ID
- ALB-BET-2011-01
- Acronym
- ALB-BET
- Status last verified
- Jun 2016
- First submitted
- 10 Jun 2014
- Last updated
- 11 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tellez L, Ibanez-Samaniego L, Perez Del Villar C, Yotti R, Martinez J, Carrion L, Rodriguez de Santiago E, Rivera M, Gonzalez-Mansilla A, Pastor O, Bermejo J, Banares R, Albillos A. Non-selective beta-blockers impair global circulatory homeostasis and renal function in cirrhotic patients with refractory ascites. J Hepatol. 2020 Dec;73(6):1404-1414. doi: 10.1016/j.jhep.2020.05.011. Epub 2020 May 21.
PubMed 32446716
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Beta-adrenergic Blockers on Cardiac Function, Systemic and Splanchnic Haemodynamic and Kidney Function in Cirrhotic Patiets With Refractory Ascites
- ClinicalTrials.gov ID
- NCT02163512
- Acronym / sponsor ID
- ALB-BET / ALB-BET-2011-01
- Conditions
- Hepatic Cirrhosis
- Keywords
- Hepatic cirrhosis, Ascites, Beta blockers treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y CajalUniversity, hospital or other
- Study start
- 12 Mar 2014 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 13 Jun 2014 (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.
Multicentric, observational and prospective study with two groups of treatment: Refractory ascites and non-refractory ascites. All patients should be prescribed beta-adrenergic blockers as primary or secondary profilaxis for variceal bleeding.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-refractory ascites | – | – |
| Refractory ascites | – | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with hepatic cirrhoris and refractory or non-refractory ascites. These patients are going to be treated with beta blockers as primary or secondary prophylaxis of variceal bleeding
Key inclusion criteria (6 listed)
- Patients aged 18-80
- Patients previously prescribed with beta-blockers
- Any type of hepatic cirrosis that has been diagnosed by clinical, analytic and image criteria
- Mild to serious ascites. Classification on refractory or non-refractory ascites depends on the patient´s response to diuretic treatment. Refractory ascites is defined by the Ascites´Board International Criteria as the lack of response, ascites recurrency or complications occurrence by diuretic drugs uptake
- Esophageal varicose vein in which beta blockers treatment is indicated as primary or secondary prophylaxis. Primary prophylaxis is indicated for big esophageal varicose veins, small varicose veins with red signs or varicose veins in patients with B-C Child-Pugh stage. Secondary prophylaxis is indicated for all those patients that have previously presented varicose bleeding.
Key exclusion criteria (12 listed)
- Hepatocellular carcinoma >5 cm
- Total portal vein thrombosis or Cavernous transformation of the portal vein
- Insuficiencia renal (creatinina sérica >3 mg/dl).
- Kidney insufficiency (seric creatinine >3 mg/dl)
- Contraindications to beta-blockers: Cardiac or breathing insufficiency, auricular-ventricular blocking grade >1.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cardiac function
Time frame: Baseline and after 4 weeks
* Echocardiography: changes in left ventricular ejection fraction, cardiac output, * Electrocardiography: changes in Qt interval
Kidney function
Time frame: Baseline and after 4 weeks
* Echocardiography: Renal vascular Doppler ultrasonographic parameters (resistive index of kidney arteries) * Blood test: serum creatinine, estimated glomerular filtration rate (eGFR) calculated by the Modification of Diet in Renal Disease formula, IL18, KIM1, NGAL
1 secondary outcome
Inflammatory markers and vasoactive endogenous system
Time frame: Baseline and after 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2019.
- Derived from this study: PubMed 32446716Tellez L, Ibanez-Samaniego L, Perez Del Villar C, Yotti R, Martinez J, Carrion L, Rodriguez de Santiago E, Rivera M, Gonzalez-Mansilla A, Pastor O, Bermejo J, Banares R, Albillos A. Non-selective beta-blockers impair global circulatory homeostasis and renal function in cirrhotic patients with refractory ascites. J Hepatol. 2020 Dec;73(6):1404-1414. doi: 10.1016/j.jhep.2020.05.011. Epub 2020 May 21.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatic Cirrhosis, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 2 sites in Spain.
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 6 inclusion and 12 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: finished, as of the sponsor's last update on 11 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cardiac function (time frame: Baseline and after 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02163512, which also lists 1 linked publication.
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 11 Feb 2019; AzTrials last refreshed its copy on 31 Oct 2026.