Congestive Heart Failure, Renal Insufficiency
Conditions
Brief summary
The researchers hypothesize that the addition of nesiritide to standard therapy will prevent worsening of renal function in patients admitted to the hospital with decompensated heart failure and renal dysfunction relative to standard therapy alone.
Interventions
DRUGNesiritide
Nesiritide: 1 mcg/kg bolus, followed by a continuous infusion at 0.005 mcg/kg/min which can be titrated every 3 hours by 0.005 mcg/kg/min to maximum dose of 0.03 mcg/kg/min until adequate diuresis achieved.
Sponsors
Scios, Inc.
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Decompensated heart failure hospitalization with at least 1 symptom and 1 sign of elevated filling pressures * Admission estimated creatinine clearance =\< 50 cc/min.
Exclusion criteria
* Systolic blood pressure \< 85 mm Hg * Cardiogenic shock * Volume depletion * Myocardial infarction, unstable angina within last 30 days * Significant valvular stenosis, hypertrophic/restrictive cardiomyopathy, or constrictive pericarditis * Chronic hemodialysis * Anticipated major procedure during hospitalization i.e. left heart catheterization, surgery, or transplantation * Enrolled in another research protocol within last 30 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Renal function | within 7 days after randomization |
Secondary
| Measure | Time frame |
|---|---|
| Weight loss | Within 7 days from randomization |
| Days to optimal volume status | From randomization till day 7 or sooner |
| Concomitant diuretic use | Within 7 days from randomization |
| Global symptom assessment | 24 hrs and 3 days after randomization |
| Length of stay | From admission to discharge or day 7 |
Countries
United States
Outcome results
None listed