The objective is to evaluate the efficacy and safety on the tolvaptan for increasing serum Na levels in patients with worsening heart failure and hyponatremia.
This is a phase 4, multicenter, randomized, double-blind, placebo-controlled, parallel-group interventional study comparing tolvaptan (15 to 60 mg) to placebo in adult patients hospitalized (or admission to emergency room) due to worsening of heart failure and dilutional hyponatremia. All patients will be on standard therapy for heart failure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
58
Seoul National University Bundang Hospital
Seoul, South Korea
Average daily AUC of change from baseline in serum Na level to day 4 within the double-blind treatment period
Time frame: from baseline to day 4
Average amount of furosemide used during hospitalization.
Time frame: from day 1 to discharge date (up to subject condition day 2 ~ day 30)
Average amount of furosemide used during out-patient period.
Time frame: from baseline to day 30 and day 60
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