Multicenter, Randomized, Double-Blind, Placebo-Controlled Study on the Effect of Oral Tolvaptan on Left Ventricular Dilation and Function in Patients With Heart Failure and Systolic Dysfunction

Multicenter, Randomized, Double-Blind, Placebo-Controlled Study on the Effect of Oral Tolvaptan on Left Ventricular Dilation and Function in Patients With Heart Failure and Systolic Dysfunction James E. Udelson, Frank A. McGrew, Enrique Flores, Hassan Ibrahim, Stewart Katz, Gregory Koshkarian, Terrence O’Brien, Marvin W. Kronenberg, Christopher Zimmer, Cesare Orlandi, Marvin A. Konstam In a multicenter, randomized, double-blind, placebo-controlled trial in patients with heart failure and reduced left ventricular systolic function, 1 year of administration of tolvaptan 30 mg/day was studied to evaluate the effect on reducing left ventricular (LV) end-diastolic volume compared with placebo by using quantitative radionuclide ventriculography. A total of 240 patients were randomized. In a well-treated population of stable HF patients, LV volumes were stable during 1 year of follow-up. There was no significant effect of tolvaptan therapy on LV volumes observed during 1 year of therapy. Nonprespecified natural history data favored therapy with tolvaptan, with a reduction in the combined end point of mortality and heart failure hospitalization observed over the course of the trial.