- Question
- Does an intravenous infusion of ularitide, a natriuretic vasodilator, added to standard therapy in acute heart failure improve the early clinical course and reduce long-term cardiovascular mortality?
- Design
- Phase 3, multicenter, randomized, double-blind, placebo-controlled trial enrolling 2157 patients. Treatment started a median of 6 hours after the initial clinical evaluation, with a median follow-up of 15 months.
- Population
- Patients with acute decompensated heart failure receiving accepted standard therapy.
- Intervention
- Continuous intravenous ularitide infusion at 15 ng/kg of body weight per minute for 48 hours, in addition to standard therapy.
- Control
- Matching placebo infusion for 48 hours, in addition to standard therapy.
- Primary outcome
- Two coprimary endpoints: death from cardiovascular causes during follow-up and a hierarchical composite evaluating the clinical course over the first 48 hours.
- Results
- Cardiovascular death occurred in 236 patients with ularitide and 225 with placebo (21.7% vs. 21.0%; HR 1.03; 96% CI 0.85 to 1.25; P=0.75). There was no significant difference in the hierarchical composite. Ularitide produced greater reductions in systolic blood pressure and NT-proBNP, with no difference in troponin T.
- Conclusion
- Ularitide had favorable physiological effects, but short-term treatment did not change the clinical composite or reduce long-term cardiovascular mortality.
- Why it matters
- It showed that improving hemodynamic parameters and biomarkers with an early intravenous vasodilator does not translate into better prognosis, which discouraged this strategy in acute heart failure.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 18, 2026