Cirrhosis is the end-stage of chronic liver disease. As a consequence of cirrhosis, portal hypertension may develop and entail neuro-hormonal changes including vasodilation and arterial hypotension causing activation of the renin-angiotensin-aldosterone and sympathetic nervous systems, and secretion of vasopressin. Fluid in the abdominal cavity (ascites) is a frequent complication induced by the increased portal pressure in patients with cirrhosis. A sodium restricted diet in addition to diuretic pharmacotherapy is usually an effective treatment to reduce the ascites burden. However, 5-10 % of patients develop refractory ascites, with a need for frequent percutaneous drainages and a reduced overall survival. New and improved treatments of refractory ascites are warranted.
Ularitide belongs to the natriuretic peptide family with a primary function to inhibit sodium reabsorption in the collecting ducts, thereby increasing sodium and water excretion by the kidneys. Such effects may counterbalance pathophysiological steps in the process of ascites formation.
We investigate the efficacy, tolerability and safety of Ularitide in patients with cirrhosis and refractory ascites in a single-center, randomized, double-blind, placebo-controlled trial. During hospitalization, participants are given Ularitide or placebo as a continuous intravenous infusion for up to 48 hours. Primary endpoints include increase in urine output, increase in urinary sodium excretion, as well as reduction in body weight. Ultimately, the results from this clinical trial may conclude on the clinical potential of natriuretic peptides in treating refractory ascites.