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

Phase 2

Completed

• Conditions: Congestive Heart Failure; Renal Insufficiency
• Interventions: Drug: Nesiritide

• Registration Number: NCT00119691
• Lead Sponsor: Brigham and Women's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-04
• Study First Submitted: 2005-07-07
• Study First Submitted QC: 2005-07-07
• Study First Posted: 2005-07-14
• Primary Completion: 2005-11
• Study Completion: 2005-11
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-11
• Last Update Posted: 2013-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of care	Nesiritide	Standard of care until adequate diuresis achieved
Nesiritide + standard of care	Nesiritide	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.

Primary Outcome Measures

Name	Time	Method
Renal function	within 7 days after randomization

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States