This study will look at how a single dose of study medication (tolvaptan) versus an inactive sugar pill (placebo) effect pressures in the heart in patients with congestive heart failure. Higher than normal pressures can be related to symptoms of heart failure (shortness of breath, fatigue, etc.).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
140
Change in heart pressures (PCWP) at 3 to 8 hours post-dose
Change in heart function measurements (CI, SVR, PVR, RAP) at 3 to 8 hours post-dose
Change in urine output and free water clearance
Change from baseline in urine osmolality
Cmax, tmax, and AUC 12h of tolvaptan in plasma
Adverse events, vital signs and clinical labs
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Oracle Research, A Div of the Heart Center
Huntsville, Alabama, United States
Merced Heart Associates
Merced, California, United States
Olive View-UCLA Medical Center
Sylmar, California, United States
Broward General Medical Center
Fort Lauderdale, Florida, United States
Cardiovascular Center at Shands Jacksonville
Jacksonville, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
ACRI
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Robert Rush University Medical Center
Chicago, Illinois, United States
Loyola University of Chicago
Maywood, Illinois, United States
...and 21 more locations