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

NCT ID: NCT00119691

Last Updated: 2013-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2005-11-30

Brief Summary

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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

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Conditions

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Congestive Heart Failure Renal Insufficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Nesiritide

Intervention Type DRUG

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

Standard of care until adequate diuresis achieved

Group Type ACTIVE_COMPARATOR

Nesiritide

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Natrecor

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Scios, Inc.

INDUSTRY

Sponsor Role collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Anju Nohria

Associate Physician/Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anju Nohria, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

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Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2003-P00235

Identifier Type: -

Identifier Source: org_study_id