Cardiac-induced Edema Clinical Trial
Official title:
A Multicenter, Double-blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tolvaptan in the Treatment of Cardiac-Induced Edema in Patients With Heart Failure
A Multicenter, Double-blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tolvaptan in the Treatment of Cardiac-Induced Edema in Patients with Heart Failure
Interventional, phase III, 2-arm parallel group, placebo-controlled, multicenter, randomized 1:1, double-blind study, comparing Tolvaptan and placebo in hospitalized HF patients with signs or symptoms of congestion at the time of randomization in spite of standard therapy.This study intends to demonstrate that a repeated 4-day treatment with Tolvaptan in addition to standard of care (SOC) is superior to SOC alone for the treatment of clinical relevant cardiac-induced volume retention parameters in patients hospitalized for worsening HF initially treated with conventional therapy including diuretics. ;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment