The purpose of this study is to evaluate the short term efficacy and safety of tolvaptan in subjects hospitalized for worsening heart failure who have volume overload and one of the following: renal insufficiency, or hyponatremia or inadequate response to diuretic therapy. The primary variable for assessing efficacy will be self-assessed 7-point dyspnea score at 8 and 16 hours.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
250
uncoated tablet, 30mg, once per day, for up to 7 days.
sugar pill
University of Alabama at Birmingham
Birmingham, Alabama, United States
The Heart Center Research
Huntsville, Alabama, United States
Greater Los Angeles VA Medical Center
Los Angeles, California, United States
University of Florida Health Science Ctr. Jacksonville
Jacksonville, Florida, United States
MIMA Century Research Associates
Melbourne, Florida, United States
To evaluate the short term efficacy and safety of tolvaptan in subjects hospitalized for worsening heart failure who have volume overload and one of the following: renal insufficiency, or hyponatremia or inadequate response to diuretic therapy.
The primary variable for assessing efficacy will be self-assessed 7-point dyspnea score at 8 and 16 hours.
Time frame: 8 and 16 hours
Change from baseline in body weight measured daily while hospitalized up to 7 days.
Change from baseline in body weight measured daily while hospitalized up to 7 days.
Time frame: up to 7 days
Diuretic dose measured daily while hospitalized up to 7 days.
Diuretic dose measured daily while hospitalized up to 7 days.
Time frame: up to 7 days.
Change from baseline in estimated glomerular filtration rate (eGFR) at discharge or day 7, whichever comes first.
Change from baseline in estimated glomerular filtration rate (eGFR) at discharge or day 7, whichever comes first.
Time frame: at discharge or day 7, whichever comes first.
Days alive and out of the hospital over 30 days
Days alive and out of the hospital over 30 days
Time frame: 30 days.
Change from baseline in cognitive function at 48 hours or discharge, whichever comes first
Change from baseline in cognitive function at 48 hours or discharge, whichever comes first
Time frame: at 48 hours or dischage, whichever comes first
Re-hospitalization for worsening heart failure or death at 30 days
Re-hospitalization for worsening heart failure or death at 30 days
Time frame: 30 days.
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