Clinical InvestigationCongestive Heart FailureEffects of the renal natriuretic peptide urodilatin (ularitide) in patients with decompensated chronic heart failure: A double-blind, placebo-controlled, ascending-dose trial
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Study design
This double-blind, placebo-controlled, ascending-dose study in patients with DHF was performed in 2 centers. For safety reasons, patients were randomly assigned to 3 urodilatin-dose groups (7.5, 15, and 30 ng/(kg · min)) in ascending order, beginning with 7.5 ng/(kg · min). In each dose group, 6 patients were treated with urodilatin and 2 patients with placebo.
All patients received their basal cardiovascular medication. During a 5-hour period (beginning 3 hours before start of study drug
Concomitant cardiac medication
Twenty-four patients were enrolled in 2 centers. Patients' basal cardiovascular medications included oral loop diuretics, thiazides, ACE inhibitors/angiotensin I blockers, β-blockers, spironolactone, and glycosides. Patients of the placebo and the 7.5 ng/(kg · min) groups more frequently received as basal medication hemodynamically acting nitrates and loop diuretics (Table I, Table III). IV dopamine infusions were ongoing at constant rates in 1 patient of the placebo and 1 in the 7.5 ng/(kg ·
Discussion
In this study, 24-hour infusions of ascending urodilatin doses result in beneficial hemodynamic and neurohumoral effects in patients with DHF. This is the first report on the treatment of DHF using a 24-hour urodilatin infusion.
Urodilatin in a dose of 30 ng/(kg · min) causes substantial decreases in PCWP and RAP compared with placebo at 6 hours, whereas in the 7.5 ng/(kg · min) group, no effect of urodilatin is observed. Urodilatin exerts vasodilatory effects.6 Therefore, decreased cardiac
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Hartmut Lüss, Erik Maronde, Katrin Fricke, Kristin Forssmann, Wolf-Georg Forssmann, and Markus Meyer are CardioPep Pharma employees. Veselin Mitrovic and Klaus Nitsche received consultant fees from CardioPep Pharma.