Nesiritide Infusion for the Treatment of Decompensated Heart Failure and Renal Dysfunction

Mass General Brigham

Status and phase: Completed; Phase 2

Conditions: Renal Insufficiency; Congestive Heart Failure

Treatments: Drug: Nesiritide

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00119691

2003-P00235

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

Nesiritide + standard of care

Experimental group

Description:

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.

Treatment:

Drug: Nesiritide

Standard of care

Active Comparator group

Description:

Standard of care until adequate diuresis achieved

Treatment:

Drug: Nesiritide