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

September 11, 2013 updated by: Anju Nohria, Brigham and Women's Hospital
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
Other Names:
  • Natrecor
Active Comparator: Standard of care
Standard of care until adequate diuresis achieved
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.
Other Names:
  • Natrecor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Renal function
Time Frame: within 7 days after randomization
within 7 days after randomization

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Collaborators

Scios, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2003

Primary Completion (Actual)

November 1, 2005

Study Completion (Actual)

November 1, 2005

Study Registration Dates

First Submitted

July 7, 2005

First Submitted That Met QC Criteria

July 7, 2005

First Posted (Estimate)

July 14, 2005

Study Record Updates

Last Update Posted (Estimate)

September 12, 2013

Last Update Submitted That Met QC Criteria

September 11, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2003-P00235

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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