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

• ClinicalTrials.gov Identifier: NCT00119691
• Recruitment Status: Completed
• First Posted: July 14, 2005
• Last Update Posted: September 12, 2013
• Sponsor: Brigham and Women's Hospital
• Collaborator: Scios, Inc.
• Information provided by (Responsible Party): Anju Nohria, Brigham and Women's Hospital

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.

Condition or disease	Intervention/treatment	Phase
Congestive Heart Failure; Renal Insufficiency	Drug: Nesiritide	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 34 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Nesiritide Infusion for the Treatment of Decompensated Heart Failure and Renal Dysfunction
• Study Start Date: April 2003
• Actual Primary Completion Date: November 2005
• Actual Study Completion Date: November 2005

Arms and Interventions

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 Name: 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 Name: Natrecor

Outcome Measures

Primary Outcome Measures :

1. Renal function [ Time Frame: within 7 days after randomization ]

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Massachusetts

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Brigham and Women's Hospital

Scios, Inc.

Investigators

• Principal Investigator: Anju Nohria, MD; Brigham and Women's Hospital

More Information

• Responsible Party: Anju Nohria, Associate Physician/Assistant Professor, Brigham and Women's Hospital
• ClinicalTrials.gov Identifier: NCT00119691
• Other Study ID Numbers: 2003-P00235
• First Posted: July 14, 2005
• Last Update Posted: September 12, 2013
• Last Verified: September 2013

Additional relevant MeSH terms:

Renal Insufficiency; Heart Failure; Heart Diseases; Cardiovascular Diseases; Kidney Diseases; Urologic Diseases; Natriuretic Peptide, Brain; Natriuretic Agents; Physiological Effects of Drugs