Clinical Trial: Efficacy and Safety of Tolvaptan in the Treatment of Cardiac-Induced Edema in Patients With Heart Failure

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Wi

Brief Summary: 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

Detailed Summary: 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.
Sponsor: Taiwan Otsuka Pharm. Co., Ltd

Current Primary Outcome: Change in body weight at 4-day of treatment. [ Time Frame: baseline and 4-day of treatment ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in Intake/Output Balance at 4-day of Treatment [ Time Frame: baseline and 4-day of treatment ]
  • Change in Serum Sodium and Potassium Concentration at 4-day of treatment [ Time Frame: baseline and 4-day of treatment ]
  • Treatment Failure at 4-day of Treatment [ Time Frame: baseline and 4-day of treatment ]
  • Changes in Physician-assessed Signs and Symptoms of Heart Failure at 4-day of Treatment [ Time Frame: baseline and 4-day of treatment ]
  • Changes in Patient Self-assessed Global Clinical Status at 4-day of Treatment [ Time Frame: baseline and 4-day of treatment ]
  • Changes in Patient Self-assessed Dyspnea Status at 4-day of Treatment [ Time Frame: baseline and 4-day of treatment ]
  • All-cause Mortality during the Study Period [ Time Frame: Duration of hospital stay for 4 days, post-study follow up visit for 2 times ]
    Total timeframe expected average of 37 days for each participant


Original Secondary Outcome: Same as current

Information By: Taiwan Otsuka Pharm. Co., Ltd

Dates:
Date Received: June 5, 2012
Date Started: July 2012
Date Completion:
Last Updated: June 1, 2015
Last Verified: January 2013