The Use of Tolvaptan to Prevent Renal Dysfunction in High Risk Patients With Heart Failure-Pilot Study
Status:
Withdrawn
Trial end date:
2013-11-01
Target enrollment:
Participant gender:
Summary
It is well known that the use of loop diuretics in acute setting may decrease glomerular
filtration rate (GFR) and increase serum creatinine leading to renal dysfunction. Loop
diuretic induced elevation in serum creatinine can lead to increase in length of hospital
stay and possibly morbidity. Previous studies have suggested that tolvaptan unlike aggressive
loop diuretic therapy may not activate neurohormonal system nor decrease renal blood flow.
These properties may make tolvaptan a useful addition to diuretic therapy to prevent renal
dysfunction in high-risk patients. Therefore the primary objective of this study is to
determine if the use of tolvaptan in combination with diuretic therapy may prevent
development of renal dysfunction in high risk patients with heart failure.
Hypothesis: Administration of tolvaptan in combination with continuous loop diuretic therapy
in acutely decompensated heart failure patients at high risk for developing diuretic induced
renal dysfunction will have a lower proportion of patients increasing their serum creatinine
> 0.3 mg/dL within a 96 hour time frame as compared to patients just receiving standard of
care continuous infusion diuretic.