portal hypertension in cirrhotic patients MedDRA version: 17.0 Level: HLT Classification code 10036201 Term: Portal hypertensions System Organ Class: 100000004866 MedDRA version: 17.0 Level: LLT Classification code 10009211 Term: Cirrhosis liver System Organ Class: 100000004871
Conditions
Interventions
Product Name: 5-methil tetrahydrofolate
Product Code: 5-MTHF
Pharmaceutical Form: Capsule
INN or Proposed INN: 5-METHYLTETRAHYDROFOLATE DI CALCIUM PENTAHYDRATE
Other descriptive name: 5-METHYLTETRAHYD
Sponsors
AOU di Bologna Policlinico S.Orsola-Malpighi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Liver cirrhosis demonstrated in terms of clinical, biochemical, imaging (echo-doppler upper abdomen, liver elastography). In the case of doubtful diagnosis is scheduled to run hepatic histology • HVPG = 12 mmHg • Presence of esophageal varices requiring the prophylaxis of bleeding from rupture (as indicated by guidelines Baveno V [7]) • Aged between 18 and 80 years • Females and males • Signature of informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: Presence of HCC at the time of enrollment or within 3 months prior • The presence of portal vein thrombosis at the time of enrollment or within 3 months prior • Presence of acute infections or conditions compromising hemodynamic stability at the time of enrollment or during the previous month • Serum creatinine> 2.5 mg / dL at enrollment • Direct bilirubin> 6 mg / dL at enrollment • Contraindications to beta-blockers at enrollment • Women who are pregnant and / or lactating at the time of enrollment • Known or suspected hypersensitivity to the drug or drug class in studio • Patients with serious medical conditions at enrollment who, in the opinion of the investigator, contraindicate the patient's participation in the study • Use of experimental drugs in the last 3 months before inclusion in the study • Treatment for hepatitis C in place at the time of study or in the previous 3 months • Treatment for hepatitis B undertaken by less than 3 months at the time of enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate if a 3-months association of oral 5-MTHF to ‘non selective’ ß-blockers can allow a significantly higher HVPG reduction in patients with liver cirrhosis in primary prophylaxis of variceal bleeding than ß-blockers alone;Secondary Objective: 1) To evaluate the tolerability of 5-MTHF n patients with cirrhosis and portal hypertension 2) To evaluate if there is an improvement of intrahepatic vascular tone mediated through diminished oxidative stress and major NO bioavailability in the hepatic microcirculation in patients with cirrhosis treated with propranolol+5-MTHF compared to patients treated with propranolol alone. This outcome will be evaluated by testing ADMA, tHcy and BH4 levels at baseline and after 3 months of oral administration of propranolol+5-MTHF or propranolol+placebo and by comparing the respectively obtained biomarkers levels in the two groups of patients ;Primary end point(s): To evaluate if a 3-months association of oral 5-MTHF to ‘non selective’ ß-blockers can allow a significantly higher HVPG reduction in patients with liver cirrhosis in primary prophylaxis of variceal bleeding than ß-blockers alone.;Timepoint(s) of evaluation of this end point: 3 months + 2 weeks follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To evaluate the tolerability of 5-MTHF n patients with cirrhosis and portal hypertension 2) To evaluate if there is an improvement of intrahepatic vascular tone mediated through diminished oxidative stress and major NO bioavailability in the hepatic microcirculation in patients with cirrhosis treated with propranolol+5-MTHF compared to patients treated with propranolol alone. This outcome will be evaluated by testing ADMA, tHcy and BH4 levels at baseline and after 3 months of oral administration of propranolol+5-MTHF or propranolol+placebo and by comparing the respectively obtained biomarkers levels in the two groups of patients. ;Timepoint(s) of evaluation of this end point: 3 months + 2 weeks follow-up | — |
Countries
Italy
Contacts
Public ContactU.O. Semeiotica Medica
AOU di Bologna Pliclinico S.Orsola-Malpighi
Outcome results
None listed