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European Heart Journal Advance Access published online on October 30, 2006
European Heart Journal, doi:10.1093/eurheartj/ehl337
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European Heart Journal © The European Society of Cardiology 2006; all rights reserved
Received May 18, 2006
Revised August 18, 2006
Accepted October 5, 2006

Clinical research

Haemodynamic and clinical effects of ularitide in decompensated heart failure

Veselin Mitrovic 1, Petar M. Seferovic 2, Dejan Simeunovic 2, Arsen D. Ristic 2, Milutin Miric 3, Valentin S. Moiseyev 4, Zhanna Kobalava 4, Klaus Nitsche 5, Wolf-Georg Forssmann 6, Hartmut Lüss 7, and Markus Meyer 7 *

1 Kerckhoff-Klinik, Bad Nauheim, Germany
2 Department of Cardiology, Institute for Cardiovascular Diseases, University Medical Center of Serbia, Belgrade, Serbia
3 ‘Zvezdara’ University Clinical and Medical Center, Belgrade, Serbia
4 Russian Peoples Friendship University, Moscow, Russian Federation
5 Hospital St. Vincenz, Limburg, Germany
6 Division of Experimental and Clinical Peptide Research, Center of Pharmacology and Toxicology, Hannover Medical School, Hannover, Germany
7 CardioPep Pharma GmbH, Karl-Wiechert-Allee 76, D-30625 Hannover, Germany

* To whom correspondence should be addressed.
Markus Meyer, E-mail: mmeyer{at}cardiopep.de


  Abstract

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 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 DHF patients. These results suggest that ularitide may play a role in the management of DHF.

Keywords: Natriuretic peptide; Urodilatin; Ularitide; Decompensated heart failure; Congestive heart failure; Randomized clinical trial.
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