Targeting Acute Congestion With Tolvaptan in Congestive Heart Failure - TACTICS-HF

Mar 24, 2017
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Otsuka Pharmaceuticals
Date Presented:
09/18/2016
Date Published:
09/18/2016
Original Posted Date:
03/24/2017
References

Description:

The goal of the trial was to evaluate treatment with the vasopressin-2 receptor antagonist tolvaptan compared with placebo among patients admitted to the hospital with acute heart failure. Vasopressin-2 receptor antagonists are designed to promote aquaresis.

Contribution to the Literature: The TACTICS-HF trial failed to show that tolvaptan was superior to placebo at improving heart failure symptoms at 24 hours.

Study Design

  • Randomized
  • Parallel
  • Blinded

Patients with acute heart failure (reduced or preserved ejection fraction) were randomized to tolvaptan 30 mg at 0, 24, and 48 hours (n = 129) versus placebo (n = 128). All patients received background intravenous diuretic therapy.

  • Total number of enrollees: 257
  • Duration of follow-up: 48 hours
  • Mean patient age: 65 years
  • Percentage female: 34%
  • Percentage diabetics: 55%
  • Mean ejection fraction: 32%

Inclusion criteria:

  • Patients admitted with acute heart failure
  • Serum sodium ≤140 mmol/L

Exclusion criteria:

  • Hypotension
  • Significant renal dysfunction
  • Intravenous vasoactive therapy or ultrafiltration

Principal Findings:

The primary outcome, % responders at 24 hours (moderate or marked improvement and no need for rescue therapy or death), was 16% with tolvaptan versus 20% with placebo (p = 0.32).

Secondary outcomes:

  • Dyspnea relief (moderate or better) at 24 hours: 50% of the tolvaptan group versus 47% of the placebo group (p = 0.80)
  • Mean fluid loss at 24 hours: 2182 cc with tolvaptan versus 1541 cc with placebo (p = 0.006)

Interpretation:

Among patients hospitalized with acute heart failure and treated with standard intravenous diuretic therapy, the addition of tolvaptan versus placebo did not improve dyspnea symptoms. Despite no improvement in dyspnea, tolvaptan was associated with greater volume loss. These findings are similar to the EVEREST and ACTIV in CHF studies.

References:

Felker GM, Mentz RJ, Cole R, et al. Efficacy and Safety of Tolvaptan in Patients Hospitalized With Acute Heart Failure. J Am Coll Cardiol 2017;69:1399-1406.

Editorial Comment: Starling RC, Young JB. Tolvaptan in Acute Heart Failure: Time to Move On. J Am Coll Cardiol 2017;69:1407-1408.

Keywords: Benzazepines, Diuretics, Dyspnea, Heart Failure, Secondary Prevention, Sodium, Stroke Volume, Vasopressins, Weight Loss


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