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

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2005

Interventions

  • Drug: 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.

Arms, Groups and Cohorts

  • Experimental: Nesiritide + standard of care
    • 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.
  • Active Comparator: Standard of care
    • Standard of care until adequate diuresis achieved

Clinical Trial Outcome Measures

Primary Measures

  • Renal function
    • Time Frame: within 7 days after randomization

Secondary Measures

  • Weight loss
    • Time Frame: Within 7 days from randomization
  • Days to optimal volume status
    • Time Frame: From randomization till day 7 or sooner
  • Concomitant diuretic use
    • Time Frame: Within 7 days from randomization
  • Global symptom assessment
    • Time Frame: 24 hrs and 3 days after randomization
  • Length of stay
    • Time Frame: From admission to discharge or day 7

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Brigham and Women’s Hospital
  • Collaborator
    • Scios, Inc.
  • Provider of Information About this Clinical Study
    • Principal Investigator: Anju Nohria, Associate Physician/Assistant Professor – Brigham and Women’s Hospital
  • Overall Official(s)
    • Anju Nohria, MD, Principal Investigator, Brigham and Women’s Hospital

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