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

Primary Purpose

Congestive Heart Failure, Renal Insufficiency

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Nesiritide
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congestive Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Brigham and Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Nesiritide + standard of care

Standard of care

Arm 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.

Standard of care until adequate diuresis achieved

Outcomes

Primary Outcome Measures

Renal function

Secondary Outcome Measures

Weight loss
Days to optimal volume status
Concomitant diuretic use
Global symptom assessment
Length of stay

Full Information

First Posted
July 7, 2005
Last Updated
September 11, 2013
Sponsor
Brigham and Women's Hospital
Collaborators
Scios, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00119691
Brief Title
Nesiritide Infusion for the Treatment of Decompensated Heart Failure and Renal Dysfunction
Official Title
Nesiritide Infusion for the Treatment of Decompensated Heart Failure and Renal Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
November 2005 (Actual)
Study Completion Date
November 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
Scios, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure, Renal Insufficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nesiritide + standard of care
Arm Type
Experimental
Arm 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.
Arm Title
Standard of care
Arm Type
Active Comparator
Arm Description
Standard of care until adequate diuresis achieved
Intervention Type
Drug
Intervention Name(s)
Nesiritide
Other Intervention Name(s)
Natrecor
Intervention 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.
Primary Outcome Measure Information:
Title
Renal function
Time Frame
within 7 days after randomization
Secondary Outcome Measure Information:
Title
Weight loss
Time Frame
Within 7 days from randomization
Title
Days to optimal volume status
Time Frame
From randomization till day 7 or sooner
Title
Concomitant diuretic use
Time Frame
Within 7 days from randomization
Title
Global symptom assessment
Time Frame
24 hrs and 3 days after randomization
Title
Length of stay
Time Frame
From admission to discharge or day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anju Nohria, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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