The purpose of this study is to determine the efficacy and safety of IV SLV320 in acute heart failure patients with renal dysfunction.
The purpose of this study is to determine the efficacy and safety of IV SLV320 in acute heart failure patients with renal dysfunction.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
46
Change in serum creatinine from baseline to Day 14
Time frame: Day 14
To compare four SLV320 doses to placebo on the change in the following variables: Dyspnea (Likert Scale and PDA scale), eGFR (MDRD Formula), Subject Global Clinical Assessment Score, Urine Osmolality, Serum Osmolality
Time frame: Up to Day 3 (Dyspnea); Up to Day 4 (Urine Osmolality); Up to Day 60 (eGFR, Subject Global Clinical Assessment Score, Serum Osmolality)
To compare the effect of four I.V. doses of SLV320 with placebo using the trichotomous endpoint of treatment success, treatment failure, or no change
Time frame: Up to Day 14
To compare the effect of four I.V. doses of SLV320 with placebo on top of diuretic use
Time frame: Up to Day 3
To compare the effect of four I.V. doses of SLV320 with placebo using a composite endpoint of all-cause mortality, cardiovascular hospitalization or hospitalization for worsening renal function, in time to event and frequency
Time frame: Up to Day 180
To determine the pharmacokinetic profile of I.V. SLV320
Time frame: Up to Day 3
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15.0mg i.v. bid
S320.2.011 Site # 548
Alameda, California, United States
S320.2.011 Site # 566
Banning, California, United States
S320.2.011 Site # 551
Inglewood, California, United States
S320.2.011 Site # 564
Bridgeport, Connecticut, United States
S320.2.011 Site # 505
Hollywood, Florida, United States
S320.2.011 Site # 507
Jacksonville, Florida, United States
S320.2.011 Site # 532
Riverdale, Georgia, United States
S320.2.011 Site # 513
Chicago, Illinois, United States
S320.2.011 Site # 561
Indianapolis, Indiana, United States
S320.2.011 Site # 526
Owensboro, Kentucky, United States
...and 95 more locations