Date: 2013-02-11
Type of information: Initiation of the trial
phase: 3
Announcement: initiation of the trial
Company: Cardiorentis (Switzerland)
Product: ularitide
Action
mechanism: Ularitide is the chemically synthesized form of urodilatin - a human, natriuretic peptide that is produced in the kidneys and induces excretion of sodium into the urine (natriuresis) and increased urine production (diuresis) to regulate fluid balance and sodium haemostasis. Ularitide induces natriuresis and diuresis by binding to specific natriuretic peptide receptors (NPR-A, NPR-B and other natriuretic peptide receptors), thereby increasing intracellular cyclic guanosine monophosphate (cGMP) helping to relax smooth muscle tissues, leading to vasodilation and increased blood flow.
Disease: acute heart failure
Therapeutic area: Cardiovascular diseases
Country: Argentina, Brazil, Canada, Chile, Colombia, Czech Republic, Estonia, Finland, France, Germany, Hungary, Italy, Latvia, Lithuania, the Netherlands, Poland, Romania, Serbia, Spain, Switzerland, Turkey, USA
Trial
details: TRUE-AHFis designed to build on the growing body of evidence that suggests patients suffering from AHF should be treated as early as possible. The trial is evaluating the following endpoints:
• A composite score that assesses the symptoms and clinical course of patients during the 48-hour infusion of ularitide.
• Cardiovascular mortality following randomisation for the entire duration of the trial
Approximately 190 centres across the US, Europe, Canada and Latin America will be involved in the TRUE-AHF trial, and approximately 2,152 patients with AHF will be randomised to receive placebo or ularitide for 48 hours in addition to standard care. (NCT01661634)
Latest
news: * On February 11, 2013, Cardiorentis has announced that it has initiated a phase III trial specifically designed to assess the effect of early treatment on cardiovascular mortality. TRUE-AHF (TRial of Ularitide\'s Efficacy and safety in patients with Acute Heart Failure) aims to show that early treatment with intravenous (IV) ularitide may reduce AHF symptoms in the short-term and cardiovascular mortality in the long-term. Health authorities have agreed with the designation of cardiovascular mortality as a primary efficacy endpoint, and patient enrolment is already underway in the US and Europe.
