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ACTIV in CHF
Acute and Chronic Therapeutic Impact of a Vasopressin antagonist in Congestive Heart Failure
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Author(s) |
(a) Gheorghiade M, Gattis WA, Barbagelata A, Adams KF Jr, Elkayam U, Orlandi C, O’Connor CM
(b) Gheorghiade M, Gattis WA, O’Connor CM, Adams KF Jr, Elkayam U, Barbagelata A, Ghali JK, Benza RL, McGrew FA, Klapholz M, Ouyang J, Orlandi C
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Title(s) |
(a) Rationale and study design for a multicenter, randomized, double-blind, placebo-controlled study of the effects of tolvaptan on the acute and chronic outcomes of patients hospitalized with worsening congestive heart failure
(b) Effects of tolvaptan, a vasopressin antagonist, in patients hospitalized with worsening heart failure
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Reference(s) |
(a) Am Heart J 2003;145:S51–4
(b) JAMA 2004;291:1963–71
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Disease |
Congestive heart failure |
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Purpose |
To evaluate the effect of tolvaptan in patients hospitalised for worsening heart failure |
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Study design |
Randomised, double-blind, placebo-controlled, parallel-group |
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Follow-up |
24 h and 7 weeks |
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Patients |
319 patients (78 tolvaptan 30 mg, 84 tolvaptan 60 mg, 77 tolvaptan 90 mg, 80 placebo), mean ages 62 years in the active treatment groups and 60 in the placebo group, with NYHA class III–IV heart failure, left ventricular ejection fraction < 40% and at least two signs of heart failure |
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Treatment regimen |
Tolvaptan, 30, 60 or 90 mg once daily, or placebo |
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Results |
Median body weight at 24 h decreased by -1.80, -2.10, -2.05 and -0.60 kg in patients receiving tolvaptan 30, 60, 90 mg/day and placebo, respectively (p ≤ 0.008 for all tolvaptan groups vs placebo). There were no significant differences in worsening heart failure between the groups treated with tolvaptan and the placebo group (p = 0.88 for trend) |
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