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

This study has been completed.
Sponsor:
Collaborator:
Scios, Inc.
Information provided by (Responsible Party):
Anju Nohria, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00119691
First received: July 7, 2005
Last updated: September 11, 2013
Last verified: September 2013
  Purpose

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 Intervention Phase
Congestive Heart Failure
Renal Insufficiency
Drug: Nesiritide
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Nesiritide Infusion for the Treatment of Decompensated Heart Failure and Renal Dysfunction

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Renal function [ Time Frame: within 7 days after randomization ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Weight loss [ Time Frame: Within 7 days from randomization ] [ Designated as safety issue: No ]
  • Days to optimal volume status [ Time Frame: From randomization till day 7 or sooner ] [ Designated as safety issue: No ]
  • Concomitant diuretic use [ Time Frame: Within 7 days from randomization ] [ Designated as safety issue: No ]
  • Global symptom assessment [ Time Frame: 24 hrs and 3 days after randomization ] [ Designated as safety issue: No ]
  • Length of stay [ Time Frame: From admission to discharge or day 7 ] [ Designated as safety issue: No ]

Enrollment: 34
Study Start Date: April 2003
Study Completion Date: November 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00119691

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

No publications provided

Responsible Party: Anju Nohria, Associate Physician/Assistant Professor, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00119691     History of Changes
Other Study ID Numbers: 2003-P00235
Study First Received: July 7, 2005
Last Updated: September 11, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Heart Failure
Renal Insufficiency
Heart Diseases
Cardiovascular Diseases
Kidney Diseases
Urologic Diseases
Natriuretic Peptide, Brain
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014