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A Safety Study Comparing Natrecor® (Nesiritide) Versus Dobutamine Therapy for Worsening Congestive Heart Failure
This study has been completed.
Sponsored by: Scios R&D, Inc.
Information provided by: Scios R&D, Inc.
ClinicalTrials.gov Identifier: NCT00270400
  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 III

MedlinePlus related topics: Heart Failure
Drug Information available for: Nesiritide Dobutamine Dobutamine hydrochloride Dobutamine lactobionate Dobutamine tartrate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Scios R&D, 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 .

Estimated Enrollment: 255
Study Start Date: July 1998
Estimated Study Completion Date: February 1999
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00270400

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

Publications of Results:
Study ID Numbers: CR005200
Study First Received: December 22, 2005
Last Updated: April 6, 2007
ClinicalTrials.gov Identifier: NCT00270400  
Health Authority: United States: Food and Drug Administration

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

Study placed in the following topic categories:
Natriuretic Peptide, Brain
Heart Failure
Heart Diseases
Cardiomyopathies
Dyspnea
Dobutamine

Additional relevant MeSH terms:
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Agonists
Adrenergic Agents
Cardiotonic Agents
Sympathomimetics
Physiological Effects of Drugs
Cardiovascular Agents
Protective Agents
Pharmacologic Actions
Adrenergic Agonists
Natriuretic Agents
Autonomic Agents
Therapeutic Uses
Cardiovascular Diseases
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009