Clinical Effectiveness of Tolvaptan in Patients With Acute Heart Failure and Renal Dysfunction

Background More efficacious and/or safer decongestive therapy is clearly needed in acute heart failure (AHF) patients complicated by renal dysfunction. We tested the hypothesis that adding tolvaptan, an oral vasopressin-2 receptor antagonist, to conventional therapy with loop diuretics would be more effective treatment in this population. Methods and Results A multicenter, open-label, randomized control trial was performed, and 217 AHF patients with renal dysfunction (estimated glomerular filtration rate 15–60 mL • min⁻¹ • 1.73 m⁻²) were randomized 1:1 to treatment with tolvaptan (n = 108) or conventional treatment (n = 109). The primary end point was 48-hour urine volume. The tolvaptan group showed more diuresis than the conventional treatment group (6464.4 vs 4999.2 mL; P < .001) despite significantly lower amounts of loop diuretic use (80 mg vs 120 mg; P < .001). Dyspnea relief was achieved significantly more frequently in the tolvaptan group at all time points within 48 hours except 6 hours after enrollment. The rate of worsening of renal function (≥0.3 mg/dL increase from baseline) was similar between the tolvaptan and conventional treatment groups (24.1% vs 27.8%, respectively; P = .642). Conclusions Adding tolvaptan to conventional treatment achieved more diuresis and relieved dyspnea symptoms in AHF patients with renal dysfunction. Clinical Trial Registration URL: http://www.umin.ac.jp/ctr/index/htm/