This is a randomized, double-blind, placebo-controlled, parallel-group forced up-titration study. Randomization will be stratified according to the patient's baseline serum sodium concentration (137-144 and \<137 mmol/L). The dose of study drug will be increased to the next level on Day 15, and the total duration of the double-blind treatment period is 120 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
338
University of Alabama at Birmingham
Birmingham, Alabama, United States
Emory University
Atlanta, Georgia, United States
University of Iowa Hospital and Clinics
Iowa City, Iowa, United States
University of Maryland School of Medicine
Clinical status at day 120.
NYHA functional class, left ventricular ejection fraction, global assessment,serum sodium concentration.
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Baltimore, Maryland, United States
Brian LGH Heart Institute
Lincoln, Nebraska, United States
The Lindner Clinical Trial Center
Cincinnati, Ohio, United States
MUSC/Division Cardiology
Charleston, South Carolina, United States
Sanofi-aventis Administrative Office
Laval, Canada
Sanofi-aventis Administrative Office
Guildford Surrey, United Kingdom