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Tolvaptan in Hospitalized Acute Heart Failure Patients
Study Questions:
Does early treatment with tolvaptan and loop diuretics improve congestion and symptoms in patients with acute heart failure (HF)?
Methods:
TACTICS-HF (Targeting Acute Congestion with Tolvaptan in Congestive Heart Failure) was a randomized, double-blind, placebo-controlled, multicenter clinical trial testing 30 mg of oral tolvaptan versus placebo given at 0, 24, and 48 hours (i.e., 3 doses) in patients hospitalized for acute HF and congestion. A total of 257 patients were randomized in a 1:1 fashion to either tolvaptan or placebo. Patients were required to have serum sodium ≤140 mmol/L and could have either HF with preserved ejection fraction (HFpEF) or HF with reduced EF (HFrEF). The primary endpoint of the study was the proportion of patients with at least moderate improvement in dyspnea by the 7-point Likert scale at both 8 and 24 hours without the need for rescue therapy or death within 24 hours.
Results:
The mean age was 65 years, 34% were women, and 41% were black. The mean EF was 33%. There was no significant difference in dyspnea measured by the Likert scale between those who received placebo and tolvaptan at 8 hours and 24 hours, and no difference in the proportion of patients classified as responders. Patients in the tolvaptan group had significantly greater weight (p = 0.004) and fluid loss (p = 0.01) throughout 48 hours. By 72 hours, there was an 8 lb weight loss in the tolvaptan group compared to 5.5 lbs in the placebo group that trended toward significance. Only 25% of patients in the tolvaptan group and 16% in the placebo group achieved complete freedom from congestion at 72 hours. As expected, there was a significant increase of approximately 3 mm/L in serum sodium in the tolvaptan group.
Conclusions:
The addition of tolvaptan to furosemide did not improve dyspnea at 24 hours or increase the proportion of responders in patients hospitalized with acute HF and congestion despite evidence of greater decongestion in the tolvaptan group.
Perspective:
The addition of tolvaptan to furosemide did not improve dyspnea at early time points (8 and 24 hours), but there was a trend toward improvement at 48 and 72 hours, which may reflect the earlier improvement in congestion. It is possible that substantial improvement could be seen with a greater level of decongestion, as only a small proportion of patients achieved complete decongestion. Better markers of decongestion are needed to evaluate efficacy of therapy in acute HF.
Keywords: Antidiuretic Agents, Benzazepines, Dyspnea, Furosemide, Heart Failure, Sodium, Stroke Volume, Vasopressins, Weight Loss
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