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

•Decongestion therapy with tolvaptan in acute heart failure patients with renal dysfunction was tested in a randomized study.•Treatment with tolvaptan achieved more urine output and dyspnea relief compared with conventional therapy.•There was no significant difference in rate of worsening renal function between groups.•Tolvaptan could be an option for treating acute heart failure patients with renal dysfunction.

BackgroundMore 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 ResultsA 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).ConclusionsAdding tolvaptan to conventional treatment achieved more diuresis and relieved dyspnea symptoms in AHF patients with renal dysfunction.Clinical Trial RegistrationURL: http://www.umin.ac.jp/ctr/index/htm/ Unique identifier: UMIN000007109