AIMS: Ularitide is a synthetic form of urodilatin, a natriuretic peptide produced in the kidney with vasodilating, natriuretic, and diuretic effects, that offers promise for the management of decompensated heart failure (DHF). We assessed the efficacy and safety of ularitide in treating patients with DHF. METHODS AND RESULTS: In this Phase II randomized, double-blind, placebo-controlled trial, 221 DHF patients received eitherplacebo (n=53) or ularitide at 7.5 ng/kg/min (n=60), 15 ng/kg/min (n=53), or 30 ng/kg/min (n=55) as a 24-h continuous infusion. At 6 h, ularitide demonstrated a significant decrease in pulmonary capillary wedge pressure (P=0.052, P=0.000004, P=0.000002, respectively) and improved dyspnoea score in the 7.5, 15, and 30 ng/kg/min ularitide group (P=0.0026, P=0.0026, P=0.0013, respectively). Ularitide reduced systemic vascular resistance and increased cardiac index for the 15 and 30 ng/kg/min groups (P=0.017, P=0.00002, respectively). Systolic blood pressure (BP) decreased dose dependency. Heart rate and serum creatinine were unchanged through day 3. Most frequently reported drug-related adverse events through day 3 in all ularitide groups were dose-dependent BP decrease and hypotension. CONCLUSION:Ularitide lowered cardiac filling pressures and improved dyspnoea without apparent early deleterious effects on renal function in DHF patients. These results suggest that ularitide may play a role in the management of DHF.
RCT Entities:
AIMS: Ularitide is a synthetic form of urodilatin, a natriuretic peptide produced in the kidney with vasodilating, natriuretic, and diuretic effects, that offers promise for the management of decompensated heart failure (DHF). We assessed the efficacy and safety of ularitide in treating patients with DHF. METHODS AND RESULTS: In this Phase II randomized, double-blind, placebo-controlled trial, 221 DHFpatients received either placebo (n=53) or ularitide at 7.5 ng/kg/min (n=60), 15 ng/kg/min (n=53), or 30 ng/kg/min (n=55) as a 24-h continuous infusion. At 6 h, ularitide demonstrated a significant decrease in pulmonary capillary wedge pressure (P=0.052, P=0.000004, P=0.000002, respectively) and improved dyspnoea score in the 7.5, 15, and 30 ng/kg/min ularitide group (P=0.0026, P=0.0026, P=0.0013, respectively). Ularitide reduced systemic vascular resistance and increased cardiac index for the 15 and 30 ng/kg/min groups (P=0.017, P=0.00002, respectively). Systolic blood pressure (BP) decreased dose dependency. Heart rate and serum creatinine were unchanged through day 3. Most frequently reported drug-related adverse events through day 3 in all ularitide groups were dose-dependent BP decrease and hypotension. CONCLUSION:Ularitide lowered cardiac filling pressures and improved dyspnoea without apparent early deleterious effects on renal function in DHFpatients. These results suggest that ularitide may play a role in the management of DHF.
Authors: Elena-Laura Antohi; Andrew P Ambrosy; Sean P Collins; Ali Ahmed; Vlad Anton Iliescu; Gad Cotter; Peter S Pang; Javed Butler; Ovidiu Chioncel Journal: Am J Ther Date: 2019 Mar/Apr Impact factor: 2.688
Authors: Horng H Chen; Omar F AbouEzzeddine; Kevin J Anstrom; Michael M Givertz; Bradley A Bart; G Michael Felker; Adrian F Hernandez; Kerry L Lee; Eugene Braunwald; Margaret M Redfield Journal: Circ Heart Fail Date: 2013-09-01 Impact factor: 8.790
Authors: P M Seferović; I Milinković; A D Ristić; J P Seferović Mitrović; K Lalić; A Jotić; V Kanjuh; N Lalić; B Maisch Journal: Herz Date: 2012-12 Impact factor: 1.443
Authors: Marco Metra; John R Teerlink; Adriaan A Voors; G Michael Felker; Olga Milo-Cotter; Beth Weatherley; Howard Dittrich; Gad Cotter Journal: Heart Fail Rev Date: 2008-12-19 Impact factor: 4.214