Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Ularitide (Urodilatin) Intravenous Infusion in Patients Suffering from Acute Decompensated Heart Failure [TRUE-AHF]
Steering Committee – Sean Collins, MD, MSc, and Phillip Levy, MD, MPH
TRUE-AHF is a phase III multicenter, international study designed to evaluate the effect of a 48h Conti-spnuous IV infusion of ularitide (15 ng/kg/min) versus placebo on the clinical status of patients with acute heart failure (AHF). Ularitide is the chemically synthesized analogue of urodilatin, a human endogenous natriuretic peptide that is expressed in the kidney and regulates renal sodium and water excretion. TRUE-AHF patients were randomized in a 1:1 manner to receive ularitide or placebo on top of usual AHF care. There were two co-primary endpoints for this study. The first is a hierarchical clinical composite variable that includes a patient-centered assessment of clinical progress, an assessment of lack of improvement or worsening of HF requiring a pre-specified intervention, and death. The second evaluates freedom from cardiovascular mortality during follow up after randomization, for the entire duration of the trial. TRUE-AHF completed recruitment in March 2016 with a total of 2157 patients enrolled. Data are currently under review.