Cirrhosis, Portal Hypertension
Conditions
Keywords
cirrhosis, portal hypertension, taurin
Brief summary
The investigators want to analyze the effect of Taurin on portal hemodynamics in patients with advanced liver cirrhosis.
Detailed description
28 days of 6 grams Taurine versus Placebo (randomization 1:1).
Interventions
DRUGTaurin 6g per day per oral for 28 days
Taurin 6g per day per oral for 28 days
PROCEDUREHVPG Measurement baseline
On day 1 (baseline) and day 28 HVPG measurement will be performed
PROCEDUREHVPG Measurement day 28
On day 1 (baseline) and day 28 HVPG measurement will be performed
DRUGPlacebo 6g per day per oral for 28 days
Placebo to Taurin 6g per day per oral for 28 days
Sponsors
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients (male and female) aged older than 18 years with advanced liver cirrhosis (Child's Grade B and Child's Grade C), regardless of the disease origin (viral, alcoholic, idiopathic), who are scheduled for hepatic hemodynamic investigation * Negative pregnancy test of women with childbearing potential * Patient without beta blocker therapy: due to: intolerance of the medication, preexisting contraindication against beta blocker therapy, endoscopic band ligation as prophylaxis
Exclusion criteria
* History of variceal bleeding without endoscopic band ligation * History of endoscopically diagnosed large varices with red spots without previous bleeding and without endoscopic band ligation * HVPG \< 10 mmHg * HVPG \> 20 mmHg and varices, unless ligated and treated in an eradication program within 6 months * Beta Blocker therapy * History of hypersensitivity to the trial drugs and contrast agent or to drugs with similar chemical structure * Treatment with vasoactive or non-steroidal anti-inflammatory drugs or systematic antibiotics one week before the study *
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HVPG change in mmHg after 28 days with Taurin 6g or placebo | 28 days | To investigate the response to 6g taurine p.o. for 28 days on the hepatic venous pressure gradient |
Countries
Austria
Outcome results
None listed