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A Safety Study Comparing Natrecor (Nesiritide) Versus Dobutamine Therapy for Worsening Congestive Heart Failure

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00270400
First Posted: December 26, 2005
Last Update Posted: June 10, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Scios, Inc.
  Purpose
The purpose of this study is to compare the effects on heart rate and ventricular arrhythmias (irregular heart beats) of two doses of Natrecor® (a recombinant form of the natural human peptide normally secreted by the heart in response to heart failure) versus dobutamine, during the first 24 hours of treatment of decompensated congestive heart failure (CHF).

Condition Intervention Phase
Heart Failure, Congestive Drug: nesiritide Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Natrecor (Nesiritide) Versus Dobutamine Therapy for Symptomatic, Decompensated CHF: A Safety Study Using 24-Hour Holter Monitoring - The PRECEDENT Trial: Prospective, Randomized Evaluation of Cardiac Ectopy With Dobutamine or Natrecor Therapy

Resource links provided by NLM:


Further study details as provided by Scios, Inc.:

Primary Outcome Measures:
  • Average heart rate; average hourly premature ventricular beats; average hourly repetitive beats, all expressed as a change from baseline

Secondary Outcome Measures:
  • Incidence of tachycardia through 24 hours; Incidence of tachycardia, pain, and injection site reaction through 14 days .

Enrollment: 255
Study Start Date: August 1998
Study Completion Date: February 1999
Arms Assigned Interventions
Experimental: 001
nesiritide
Drug: nesiritide

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • History of NYHA (New York Heart Association) Class III or IV congestive heart failure (CHF)
  • Has symptomatic, decompensated CHF for which inpatient therapy with either dobutamine or Natrecor®, administered as a single intravenous vasoactive agent (drugs that influence the tone and caliber of blood vessels) with or without diuretics, is deemed appropriate
  • Receiving stable doses of oral antiarrhythmic medications (medications that help regulate irregular heart beats) for at least the 48 hours before starting study drug, or receiving no antiarrhythmic medications.

Exclusion Criteria:

  • Cannot tolerate a 24-Hour Baseline Holter Monitoring Period without intravenous vasoactive medications, and/or cannot tolerate the specified washout period (if applicable) of intravenous vasoactive medications before starting the baseline Holter monitoring
  • Has systolic blood pressure consistently < 85 mm Hg, cardiogenic shock, or other evidence of significant hemodynamic instability requiring the immediate institution of inotropic/pressor support
  • Has a clinical condition expected to require therapy with more than one intravenous vasoactive agent or Dopamine during the 24-Hour Treatment Holter Monitoring Period
  • Has received treatment with Dopamine or any intravenous vasoactive medication such as Dobutamine, Milrinone, Nitroprusside or intravenous Nitroglycerin for more than 4 hours for the current episode of decompensated CHF or related illness
  • Requires an intravenous antiarrhythmic medication during the 48 hours before starting the study
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00270400


Sponsors and Collaborators
Scios, Inc.
Investigators
Study Director: Scios, Inc. Clinical Trial Scios, Inc.
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00270400     History of Changes
Other Study ID Numbers: CR005200
First Submitted: December 22, 2005
First Posted: December 26, 2005
Last Update Posted: June 10, 2011
Last Verified: June 2011

Keywords provided by Scios, Inc.:
Heart Failure
Renal Dysfunction
Cardiomyopathy
Heart Decompensation
Dyspnea Paroxsymal.

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Dobutamine
Natriuretic Peptide, Brain
Cardiotonic Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Natriuretic Agents


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