NCT00119691CompletedPhase 2
Nesiritide Infusion for the Treatment of Decompensated Heart Failure and Renal Dysfunction
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Brigham and Women's Hospital
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Renal function
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Nesiritide + standard of care
Experimental
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.
Intervention: Nesiritide (Drug)
Standard of care
Active Comparator
Standard of care until adequate diuresis achieved
Intervention: Nesiritide (Drug)
Outcomes
Primary Outcomes
Renal function
Time Frame: within 7 days after randomization
Secondary Outcomes
- 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)
Investigators
Anju Nohria
Associate Physician/Assistant Professor
Brigham and Women's Hospital
Study Sites (1)
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