The Use of Tolvaptan to Prevent Renal Dysfunction in High Risk Patients With Heart Failure-Pilot Study
| Status: | Withdrawn |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 4/21/2016 |
| Start Date: | August 2012 |
| End Date: | November 2013 |
The Use of Tolvaptan to Prevent Renal Dysfunction in High Risk Patients With Acute Decompensated Heart Failure-Pilot Study
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.
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.
Inclusion Criteria:
- ≥ 18 years old
- Prior clinical diagnosis of systolic heart failure (EF < 40% within the past 18
months) with daily home use of oral loop diuretic for at least one month.
- Daily oral dose of furosemide ≥ 40 mg and ≤ 240 mg (or equivalent)
- Identified within 24 hours of hospital admission
- Heart failure defined by at least 1 symptom (dyspnea, orthopnea, or edema) AND 1 sign
(rales on auscultation, peripheral edema, ascites, pulmonary vascular congestion on
chest radiography)
- Anticipated need for IV loop diuretics for at least 48 hours
- Likely requires daily net urine output in the range of 1-3 L/day for over a 72-96
hour time period.
- Albumin level < 3.5 g/dL
- Willingness to provide informed consent
Exclusion Criteria:
- Received or planned IV vasoactive treatment (inotropes, vasodilators) or
ultra-filtration therapy for heart failure
- BNP < 250 ng/ml or NT-proBNP < 1000 mg/ml (if drawn for clinical purposes)
- Systolic BP < 90 mmHg
- Serum creatinine > 3.0 mg/dl at baseline or renal replacement therapy or creatinine
clearances < 10 mL/min
- Serum sodium > 145 mEq/L
- Acute coronary syndrome within 4 weeks
- Anticipated need for coronary angiography or other procedures requiring IV contrast.
- Patients receiving any of the following drugs: clarithromycin, ketoconazole,
itraconazole,ritonavir, indinavir, nelfinavir, saquinavir, nefazodone, telithromycin,
erythromycin, fluconazole, aprepitant, diltiazem, verapamil, cyclosporine, and
grapefruit juice.
- Pregnant or nursing patients.
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