Metoprolol Succinate in Cardiac Remodeling Related to Cirrhosis
Status:
Completed
Trial end date:
2014-03-01
Target enrollment:
Participant gender:
Summary
Cirrhotic cardiomyopathy is defined as a chronic cardiac dysfunction in patients with
cirrhosis. It is suspected that this specific cardiac dysfunction contributes to the onset of
complications in liver disease. The purpose of this prospective, randomized trial is to
determine whether metoprolol succinate can revert cardiac dysfunction secondary to cirrhosis
(cirrhotic cardiomyopathy), and prevent complications (renal dysfunction, mortality). A total
of 100 patients with cirrhotic cardiomyopathy will be randomized (Group R) to receive
metoprolol succinate or placebo; other 25 patients without cirrhotic cardiomyopathy (Group F)
will only be followed up without medication. All patients will be evaluated in the beginning
and again after six months. The assessment protocol includes clinical evaluation,
electrocardiogram, echocardiogram, laboratory analysis and life quality questionaire. The end
points will be cardiac remodeling, electrophysiologic changes, sympathetic activity,
laboratory issue changes, renal function, quality of life, and mortality.
Phase:
Phase 3
Details
Lead Sponsor:
University of Sao Paulo
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo