Vasodilation by urapidil in the treatment of chronic congestive heart failure in addition to angiotensin-converting enzyme inhibitors is not beneficial: results of a placebo-controlled, double-blind study.

BACKGROUND: The therapeutic benefit of an angiotensin-converting enzyme (ACE) inhibitor in combination with a different type of vasodilator is unknown. METHODS AND RESULTS: To evaluate the effects of a combined therapy on quality of life, exercise tolerance, and hemodynamic parameters, patients with severe heart failure (New York Heart Association classes III and IV, ejection fraction below 35%) who were on ACE inhibitor therapy were randomly assigned to additional double-blind treatment with urapidil (60-120 mg/d) or placebo for 12 weeks. After enrollment of 36 patients, the study was terminated early because no beneficial effects on exercise tolerance and hemodynamic parameters could be shown for the urapidil treatment, and a trend toward increased mortality of the urapidil group was observed (odds ratio, 4.92 [0.49-49.6]; P = .167). CONCLUSION: The combination of urapidil with an ACE inhibitor in the treatment of severe chronic congestive heart failure does not seem to offer any advantages over therapy with an ACE inhibitor alone and may have potentially harmful effects.