This study investigated a new drug, Strongheart, for the treatment of chronic heart failure.

METHODS: 3,991 patients were enrolled in this double-blind, randomized controlled study using the following inclusion criteria: diagnosis of chronic heart failure with New York Heart Association (NYHA) functional class II-IV, ejection fraction of 0.40 or less and stabilized on optimal standard therapy. Randomization was preceded by a two-week single-blind placebo run-in period. Of the 3,991 patients, 1,990 patients were randomly assigned to Strongheart 12.5 mg daily and 2,001 patients were assigned to placebo. The target dose of Strongheart was 200 mg once daily and doses were titrated up over 8 weeks. The primary endpoint was all-cause mortality, analyzed by intention to treat.

RESULTS: The study was stopped early on the recommendation of the independent safety committee. The mean follow-up period was 1 year. All-cause mortality was lower in the Strongheart group than in the placebo group [146 deaths vs. 219 deaths; p = 0.00009, (95% CI 0.53-0.81)]. There were fewer sudden deaths (79 vs. 132; p = 0.0002) and fewer deaths from worsening heart failure (30 vs. 58; p = 0.0023) in the Strongheart group compared to the placebo group.

CONCLUSIONS: Strongheart once daily improved survival in heart failure patients when added to optimal standard therapy. What is the relative risk?