UnknownPhase 2/3

Rifaximin and Propranolol Combination Therapy Versus Propranolol Monotherapy in Cirrhotic Patients

South Korea140 participantsStarted 2013-07

Plain-language summary

To reduce portal pressure, the only recommended medication is nonselective beta blocker(NSBB). However, NSBB has some limitation to apply clinically because of poor response rate and compliance. Recent literature has supported the role of bacterial translocation as a mediator of splanchnic vasodilatation and portal hypertension. This stimulates the release of pro-inflammatory cytokines and the activation of the vasodilator NO resulting in a more pronounced deterioration of the baseline hyperdynamic circulatory state. Selective gut decontamination with Rifaximin can induce inhibition of bacterial translocation and associated worsening of portal hypertension. The investigators hypothesized that Rifaximin plus NSBB could result in decrease of portal pressure in cirrhotic patients with esophageal varices.

Who can participate

Age range19 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Liver cirrhosis:diagnosed based on histology or unequivocal clinical, sonographic, and laboratory findings * 19≤age≤75 * Hepatic venous pressure gradient \> 12 mmHg * Informed consent Exclusion Criteria: * Shock status requiring vasopressor * Active infection, for example Spontaneous bacterial peritonitis * Acute renal failure patients of any cause * Clinically relevant coronary artery disease(NYHA functional angina classification III/IV),congestive heart failure NYHA III/IV), clinically relevant cardiomyopathy, history of myocardial infarction in the past 12 months * Poorly controlled hypertension (BP 150/100mmHg) * Hepatocellular carcinoma * History of another primary malignancy ≤ 3years * Medical or psychological conditions that would not permit the subject to complete thte study or sign informed consent * Pregnancy or lactation period * Serum creatinine ≧ 6mg/dL * Involvement in the conduct of other study within 30 days * Known hypersensitivity to Rifaximin or propranolol * Dysarrhythmia, inappropriate for study on investigator's judgment

What they're measuring

Hepatic vein pressure gradient(HVPG)

Timeframe: Change from baseline heptic vein pressure gradient at 6 weeks

Trial details

NCT IDNCT01897051

SponsorYonsei University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-02

Contact for this trial

Moon Young Kim, MD,PhD

82-33-741-1225 drkimmy@yonsei.ac.kr