Acute Hemodynamic Effects of Tolvaptan, a Vasopressin V2 Receptor Blocker, in Patients With Symptomatic Heart Failure and Systolic Dysfunction : An International, Multicenter, Randomized, Placebo-Controlled Trial

Objectives This study sought to assess the acute hemodynamic effect of vasopressin V 2 receptor antagonism. Background In decompensated heart failure (HF), tolvaptan, a vasopressin V 2 receptor antagonist, has been shown to improve congestion. It has not yet been established whether these improvements may be associated with the hemodynamic effects of tolvaptan. Methods A total of 181 patients with advanced HF on standard therapy were randomized to double-blind treatment with tolvaptan at a single oral dose (15, 30, or 60 mg) or placebo. Results Tolvaptan at all doses significantly reduced pulmonary capillary wedge pressure (−6.4 ± 4.1 mm Hg, −5.7 ± 4.6 mm Hg, −5.7 ± 4.3 mm Hg, and −4.2 ± 4.6 mm Hg for the 15-mg, 30-mg, 60-mg, and placebo groups, respectively; p Conclusions In patients with advanced HF, tolvaptan resulted in favorable but modest changes in filling pressures associated with a significant increase in urine output. These data provide mechanistic support for the symptomatic improvements noted with tolvaptan in patients with decompensated HF. (Heart Pressure Assessment Study With Tolvaptan to Treat Congestive Heart Failure; NCT00132886 )