Switzerland based Cardiorentis has commenced its Phase III trial of ularitide's efficacy and safety in patients with acute heart failure (TRUE-AHF) to evaluate the effect of early treatment on cardiovascular mortality and symptoms.
TRUE-AHF is indented to demonstrate the effect of early treatment with intravenous (IV) ularitide in the reduction of AHF symptoms in the short-term, and cardiovascular mortality in the long-term.
University of Texas Southwestern Medical Center clinical sciences department chair and professor, and chair of the trial Dr Milton Packer said the early decompression of the dilated heart is believed to reduce myocardial injury in patients with acutely decompensated heart failure.
"If decompression produced by a 48-hour infusion of ularitide can prevent significant myocardial damage during this vulnerable period, then we are likely to see a reduction in cardiovascular mortality over the following months and years," Packer said.
Patient enrolment is being conducted in the US and Europe for the trial, with cardiovascular mortality as a primary efficacy endpoint.
Around 2,152 AHF patients will be randomised with placebo or ularitide for 48 hours in addition to standard care.
TRUE-AHF will evaluate a composite score that assesses the symptoms and clinical course of patients during the 48-hour infusion of ularitide, and cardiovascular mortality following randomisation for the entire duration of the trial.
Cardiorentis CEO and chairman Elmar Schnee said; "We wanted the study design to reflect our belief that ularitide could provide symptom improvement and a reduction in cardiovascular mortality, which are both crucial measures for new therapies being investigated for the treatment of AHF."