Frederick A. Masoudi, MD, MSPH, FACC, FAHA reviewing Packer M et al. N Engl J Med 2017 May 18. Hauptman PJ. N Engl J Med 2017 May 18.
In TRUE-AHF, infusion of ularitide within 12 hours after clinical evaluation failed to improve clinical endpoints.
In patients with heart failure (HF), hospitalization is associated with accelerated disease progression, and no therapy for acute decompensated HF has proven effective at improving outcomes. Episodes of acute HF are characterized by evidence of left ventricular wall stress and myocardial injury, which might be attenuated by rapid decongestion. In a manufacturer-sponsored, double-blind, randomized, placebo-controlled trial, investigators assessed the effects of ularitide, a synthetic vasodilator, continuously infused for 48 hours beginning as soon as possible in 2157 patients hospitalized with acute decompensated HF (mean age, 68; 66% men).
Participants had persistent dyspnea at rest for ≥2 hours after intravenous diuretic treatment and a systolic blood pressure between 116 mm Hg and 180 mm Hg; 65% had at least moderate left ventricular systolic dysfunction. Half of the patients started treatment within 6 hours after clinical evaluation.
Ularitide showed significantly greater decreases than placebo in mean systolic BP (differences of 6.8 mm Hg at 6 hours and 3.9 mm Hg at 48 hours) and in N-terminal pro–brain natriuretic peptide levels from baseline to 48 hours. Nevertheless, the groups showed no differences in risk for death at a mean follow-up of 15 months (ularitide, 21.7%; placebo, 21.0%) or on a 48-hour hierarchical endpoint (death, persistent or worsening symptoms, or worsening global assessment). Significantly more ularitide patients discontinued treatment, primarily for hypotension, than placebo patients (18% vs. 7%).
CITATION(S):
Packer M et al. Effect of ularitide on cardiovascular mortality in acute heart failure. N Engl J Med 2017 May 18; 376:1956.
Hauptman PJ.Disease modification in acute decompensated heart failure. N Engl J Med 2017 May 18; 376:1987.
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